Instructions for Use
Cervico Essential Mold
24-well anatomical mold for fabricating custom healing abutments in flowable composite with any stock implant analog.
Document details VPI-IFU-EM · rev 2.0
- REF
- 5213006651779
- Document
- VPI-IFU-EM
- Revision
- 2.0
- Date of issue
- 2026-09-09
In the box
- Aluminium mold ring with well codes
- Silicone insert: 24 anatomical wells
6 steps
Clean and sterilize first
Non-sterile on delivery. Separate silicone from base, ultrasonic clean 10 min at 50 °C, rinse, dry, pouch, autoclave 4 min at 134 °C, dry 30 min.
Read the code
Shape a / p / m1 / m2, size S / M / L, c centered or o off-centered. m1Lc = lower molar, large, centered. The code comes from the Cervico Guide tab chosen in the mouth.
Abutment on analog, into the well
Temporary abutment on the system's lab analog. Sink the analog into the bottom hole until the abutment shoulder is level with the well floor.
Turn to the tear
Rotate until the hex flat (or your buccal mark) faces the tear-shaped bump on the front of the well.
Fill and cure
Flowable nano-hybrid composite; large wells in two increments. 60 s in the well, 60 s out.
Out, polish, disinfect
Twist out with tweezers or back the screw out while pulling. Polish smooth. Remove the analog. Disinfect like any abutment.
Never skip
- The mold never goes in the mouth; the abutment does, so polish and disinfect it.
- Wrong rotation = wrong profile in the mouth. Always align to the tear.
- Max 145 °C. Replace a torn silicone insert.
After every patient
- Wipe wells with alcohol, take the silicone out of the base, tabs and pins off the handle.
- Ultrasonic clean 10 min at 50 °C, aldehyde-, phenol- and chlorine-free detergent. Rinse with purified water. Dry.
- Inspect. Pouch. Autoclave: 4 min at 132–134 °C pre-vacuum or 30 min at 121 °C gravity. Dry 30 min.
- Never above 145 °C. Never dry heat, chemiclave, EtO or plasma.
Full instructions
This card does not replace the Instructions for Use. Read VPI-IFU-EM before first use: https://vpicervico.com/instructions-of-use/
VP INNOVATO HOLDINGS LTD · Poseidonos 4A, Aradippou 7101, Larnaca, Cyprus · +357 99 883 898 · info@vpicervico.com
REF 5213006651779 · Class I medical device, CE · Rx only (USA) · Non-sterile, sterilize before use · VPI-QSG-EM rev 2.0, 2026-09-09
VP INNOVATO HOLDINGS LTD · Poseidonos 4A, Aradippou 7101, Larnaca, Cyprus · +357 99 883 898 · info@vpicervico.com
VPI-QSG-EM revision 2.0, issued 2026-09-09. English (original). Latest version: https://vpicervico.com/instructions-of-use/
Device identification
- Trade name
- Cervico by VPI · Cervico Essential Mold
- REF
- 5213006651779
- Description
- Benchtop mold for chairside customization of stock temporary abutments into anatomical healing abutments, using the implant system's stock lab analogs.
Cervico Essential Mold · REF 5213006651779
| Component | Qty | Material |
|---|---|---|
| Mold base (ring) with laser-marked well codes | 1 | Aluminium alloy 6082, anodized |
| Silicone insert: 24 anatomical wells (a, p, m1, m2 × S, M, L × centered, off-centered) | 1 | Medical silicone |
- Each well is coded shape–size–symmetry, e.g. m1Lc = lower molar, large, centered; m1Lo = the same shape off-centered.
- Each well has a tear-shaped protrusion on its front face: the buccal reference.
- The bottom hole of each well accepts the stock lab analog of any implant system; no proprietary insert is required.
- The well to use is the one whose code matches the Cervico Guide tab selected in the mouth (Guide supplied in the Essential Kit or separately). Without the Guide, choose the tooth group from the tooth being replaced and the size from the cervical width of the future crown against the adjacent teeth.
Intended purpose, indications, contraindications
Cervico Essential Mold
Intended purpose. The Cervico Essential Mold is intended for the customization of stock temporary abutments so that they acquire a shape resembling the cervical zone of the intended implant prosthesis.
Indications. Chairside or laboratory fabrication of custom anatomical healing abutments for partially edentulous implant cases, with any implant system that provides stock lab analogs. The emergence profile is then recorded by intra-oral scan or by a conventional impression; the Essential Mold does not produce custom impression posts.
Contraindications.
- None absolute. Do not use for patients in whom implant therapy is contraindicated.
Intended users
Licensed dental professionals (dentists, oral surgeons, prosthodontists) and, for the mold devices, trained dental assistants and dental technicians working under their direction. Users must be trained in implant dentistry and have read this document.
Patient population
Patients with partial edentulism undergoing implant therapy, with completed craniofacial growth (in general 20 years and above, no upper age limit). Use in pregnant or nursing women is not recommended.
Use environment
Dental clinic or dental laboratory. Place the device on a flat, clean, dry, non-slip surface with good lighting.
Clinical benefit
Selection of an anatomically correct cervical profile and its chairside transfer to a custom healing abutment supports peri-implant soft-tissue conditioning around the correct contour from placement onward, and the accurate recording of that contour for the definitive prosthesis. Expected performance: complete, correctly oriented abutment shaped to the well within approximately 4 minutes.
Residual risks and undesirable side effects
- Aspiration or ingestion of a small part used intra-orally (Guide). Controlled by securing parts with floss or suture.
- Cross-contamination from inadequate reprocessing. Controlled by the validated reprocessing instructions.
- Malpositioned or mis-oriented healing abutment from a wrong well, orientation or depth. Controlled by the coding system, tear mark or VPI insert, and by clinical and radiographic verification at placement.
- Tissue irritation from incompletely cured or unpolished composite. Controlled by curing and polishing instructions and the composite manufacturer's IFU.
- Hypersensitivity to aluminium or stainless steel in patients with known metal allergy.
Warnings and precautions
Symbols on the label
Symbols reproduced from the product label artwork (ISO 15223-1:2021). UDI and Rx only are typographic symbols.
Devices and materials used with this device
The following are not supplied by VP Innovato Holdings and must carry their own conformity marking. Use them according to their manufacturer's instructions.
| Item | Note |
|---|---|
| Temporary abutment | One- or two-piece, titanium or PEEK, from the implant manufacturer. Core of the custom healing abutment. |
| Stock impression post | Closed- or open-tray, from the implant manufacturer. Used for the conventional impression. |
| Lab analog (Essential Mold) | Stock analog of the implant system. Carries the abutment in the well. |
| Flowable nano-hybrid composite | Light-curing composite intended for intraoral provisional use, with the manufacturer's IFU. |
| Dental curing light | Output and time per the composite manufacturer. |
| Polishing mops, brushes and composite polishing paste | To finish the composite surface. |
| Sterile PTFE (Teflon) tape | To seal the screw access channel before composite. |
Before first use
- Check the package and contents against the components list. Do not use a device with a damaged package or missing or damaged parts; contact the manufacturer or distributor.
- Remove all packaging material. Note the LOT number in your instrument records.
- Clean and sterilize every part as described in "Reprocessing". The device is supplied non-sterile.
- Read the procedures below and watch the video guides at vpicervico.com/instructions-of-use.
Instructions for use: Cervico Essential Mold
Custom healing abutment fabrication
After consultation or at surgery; about 4 minutesChoose the well
Use the well whose code matches the Cervico Guide tab chosen in the mouth (e.g. m1Lc). Centered (c) when the implant sits under the middle of the future crown, off-centered (o) when it does not. Without the Guide, choose by tooth group and the cervical width of the future crown.
Connect the abutment to its analog and seat it in the well
Connect the temporary abutment to the lab analog of the implant system. Push or screw the analog into the bottom hole of the well until the shoulder of the abutment is level with the floor of the well. This is the final vertical position.
Rotate to the tear mark
Turn the assembly until the reference mark of the prosthetic connection on the abutment (e.g. flat seat of the hex) is aligned with the tear-shaped protrusion on the front of the well. If the implant was placed with its connection not facing buccal, see "Non-buccal connection orientation" below.
Fill with composite
Fill the open space of the well with flowable nano-hybrid composite. Fill large wells in two increments so each cures fully.
Light cure
Cure per the composite manufacturer. General rule: 60 seconds in the well, then 60 seconds more after removal from the mold.
Remove from the mold
Hold the abutment pillar with tweezers and twist the assembly out, or engage the retention screw with the driver, rotate clockwise and pull.
Polish, separate and disinfect
Polish the composite with mops and polishing paste to an even, smooth surface. Disconnect the lab analog. Disinfect or sterilize the abutment as for any implant abutment before intraoral use.
Placement of the custom healing abutment
At implant placement (one-stage) or at uncoveringSeat and verify
Screw the abutment to the implant with the retention screw of the temporary abutment, torqued per the implant manufacturer. Confirm complete seating clinically and radiographically.
Seal the screw access
Place a first layer of sterile PTFE tape, then fill the remaining channel with composite and cure.
Check occlusion
Verify occlusal clearance and reduce the abutment height if needed. Allow the implant to integrate, or if the abutment was placed at uncovering allow the tissue to mature for 4 to 6 weeks.
Impression
After tissue maturationRemove the healing abutment
Remove the composite and PTFE from the screw access, unscrew and remove the abutment.
Record the profile
Scan the emergence profile with an intra-oral scanner, or take a conventional impression with a plain stock impression post. Work one implant at a time and reseat the healing abutment promptly so the tissue does not collapse.
Laboratory
The recorded emergence profile is the template for the submerged part of the prosthesis, preferably in titanium or zirconia.
Non-buccal connection orientation
When the implant's connection does not face buccalMark buccal in the mouth
Seat the temporary abutment on the implant and mark its buccal surface with a marker or a scored line.
Align the mark to the tear
In the mold, align that mark, not the connection feature, with the tear-shaped protrusion of the well, then fabricate as normal.
Reprocessing: cleaning, disinfection, sterilization
All Cervico instruments are supplied NON-STERILE and must be cleaned and sterilized before the first use and before every subsequent use. Thorough cleaning is a precondition for effective sterilization. The user is responsible for using validated equipment and for complying with local regulations and the hygiene policy of the facility.
Point of use
- Immediately after use, wipe composite residue out of the silicone wells with a cotton tip soaked in alcohol. Do not let composite cure inside a well.
- Disassemble fully: silicone insert out of the mold base, VPI Prosthetic Connection Inserts out of their sockets, Guide tabs and pins off the handle and out of the case.
- Keep the parts moist until cleaning; do not allow soil to dry on.
Automated cleaning (preferred)
- Prefer a validated washer-disinfector (EN ISO 15883) with a program suitable for dental instruments and adequate rinsing cycles.
- Use a mildly alkaline or enzymatic detergent approved for dental instruments and compatible with aluminium and silicone.
- Final rinse with purified or deionized water (max. 10 CFU/ml, 0.25 EU/ml). Dry with filtered air.
- Service, inspect and calibrate the washer-disinfector according to its manufacturer.
Manual cleaning
- Ultrasonic bath, 10 minutes at 50 °C, in an aldehyde-, phenol- and chlorine-free cleaning concentrate for dental instruments, all parts fully immersed.
- Rinse thoroughly with purified or deionized water. Manual cleaning is less effective than automated cleaning; always inspect.
- Dry completely before packaging.
Do not use
- Strong alkalines (pH above 9) or strong acids (pH below 4)
- Phenols, iodophors, halogenated hydrocarbons
- Strong oxidizers, peroxides, organic solvents
- Metal brushes or steel wool on any part
- Dry heat, radiation, formaldehyde, ethylene oxide or plasma sterilization
- Immediate-use (flash) sterilization as the routine method
Inspection and maintenance
After cleaning, inspect every part for residue, corrosion, cracks, deformation, torn or hardened silicone and wear of the tear-shaped orientation marks. Re-clean if soiled. Do not use damaged parts: replace the silicone insert or the part, or contact the manufacturer.
Packaging
Package dry parts in sterilization pouches or a cassette conforming to local standards and rated to at least 141 °C with adequate steam penetration. Size the pouch so it seals without strain.
Steam sterilization, minimum parameters
| Item | Gravity displacement | Dynamic air removal (pre-vacuum) | Drying |
|---|---|---|---|
| Cervico Guide (case, tabs, pins, handle) | 30 min at 121 °C (250 °F) | 4 min at 132–134 °C (270–273 °F) | 30 min minimum |
| Cervico Premium Mold (base, silicone insert, VPI inserts, screwdriver) | 30 min at 121 °C (250 °F) | 4 min at 132–134 °C (270–273 °F) | 30 min minimum |
| Cervico Essential Mold (base, silicone insert) | 30 min at 121 °C (250 °F) | 4 min at 132–134 °C (270–273 °F) | 30 min minimum |
- Steam sterilization only: fractionated pre-vacuum (dynamic air removal) or gravity displacement, in a sterilizer conforming to EN 13060 / EN 285 or ANSI/AAMI ST55 / ST8, validated to EN ISO 17665-1 or ANSI/AAMI ST79.
- Never exceed 145 °C. The magnetic retention handle of the Guide must not be exposed to more than 145 °C.
- Allow parts to dry and cool completely before handling. Sterilizers with an automatic drying program are recommended.
- Use only purified or deionized feed water and maintain the sterilizer per its manufacturer.
Storage after sterilization
Store sterilized, wrapped parts dry, dust-free and out of direct sunlight in the clean zone, with sterilization status marked, separated from non-sterile instruments. Unsterilized devices are stored in the original box at normal office conditions.
Reuse and service life
The devices are reusable without a fixed limit of cycles. Service life depends on frequency of use, care and correct reprocessing. Silicone inserts are wear parts: replace when wells are torn, deformed, hardened or no longer release the abutment cleanly. Inspect before every use; the user is responsible for not using damaged or soiled parts.
Troubleshooting
| Observation | Likely cause | Action |
|---|---|---|
| Abutment sits rotated in the mouth | Orientation reference not aligned to the tear mark, or the implant connection was placed off the T-line direction | Re-fabricate using the buccal mark method: mark buccal on the abutment in the mouth and align that mark to the tear. |
| Composite tears or leaves residue in the well | Undercured composite, or separating medium in an anatomical well | Cure in increments, 60 seconds in the well. Never coat anatomical wells. Clean the well with a cotton tip soaked in alcohol. |
| Silicone well torn, deformed or hardened | Wear | Replace the silicone insert. Do not keep using a damaged well. |
| Abutment too tall or too short | Lab analog not fully seated in the well | Push the analog in until the shoulder of the abutment is level with the floor of the well. Trim the height intra-orally if it is only slightly tall. |
| Abutment and analog will not come out of the well | Composite locked around the analog | Grip the remaining abutment pillar with tweezers and twist the assembly out. Alternatively engage the retention screw with the driver and rotate clockwise while pulling. |
Manufacturer, regulatory information and reporting
- Manufacturer
- VP INNOVATO HOLDINGS LTD
Poseidonos 4A, Aradippou 7101, Larnaca, Cyprus
+357 99 883 898 · info@vpicervico.com
https://innovatoholdings.com - SRN
- CY-MF-000036072
- Basic UDI-DI
- 521300665VPICW
- REF
- Cervico Essential Mold: 5213006651779
- Classification (EU)
- Class I, Rule 1 (non-invasive devices), Annex VIII, Regulation (EU) 2017/745. Conformity assessment per Annex II and III; CE marked under the manufacturer's sole responsibility. EU Declaration of Conformity available on request.
- Nomenclature
- EMDN Q010603 (non-active, non-implantable dental instrument)
- Quality system
- ISO 13485:2016, HEALTH CERT P.C. certificate 0252024MDM0054, valid to 25/06/2027
- USA
- FDA establishment registration 3014837662, owner/operator 10058387, device listing D329255, product code NDP (accessories, implant, dental, endosseous). Rx only. Caution: Federal law restricts this device to sale by or on the order of a licensed dentist or physician.
- Reporting (EU)
- Report any serious incident to the manufacturer (above) and to your national competent authority. Cyprus: Cyprus Medical Devices Competent Authority, Medical and Public Health Services, Ministry of Health, Corner of Prodromou 1 & Chilonos 17, 1449 Nicosia, Cyprus, +357 22 605 572, cymda@mphs.moh.gov.cy.
- Reporting (USA)
- Report adverse events to the manufacturer and through FDA MedWatch (www.fda.gov/medwatch).
- Disposal
- Clean and sterilize before disposal. Aluminium, steel and silicone parts are recyclable; dispose of them according to local regulations for contaminated instruments. No special hazards.
- Warranty and service
- Contact the manufacturer or your distributor. Do not attempt repairs; no user-serviceable parts other than the replaceable silicone insert.
VP INNOVATO HOLDINGS LTD · Poseidonos 4A, Aradippou 7101, Larnaca, Cyprus · +357 99 883 898 · info@vpicervico.com
VPI-IFU-EM revision 2.0, issued 2026-09-09. English (original). Latest version: https://vpicervico.com/instructions-of-use/
The Essential Kit video shows this mold in use, together with the Cervico Guide.
More on the Cervico YouTube channel →