Identity
- Trade Name
- die silicone FDA UDI
- Generic Name
- Polymer-based dental model material FDA UDI
- Device Name
- This die silicone is an addition-curing silicone for the extraoral fabrication of dental models. Indirect composite restorations can be fabricated chairside on this silicone model. The die silicone’s special curing formula allows you ample time to apply the material. The material is fully cured after 4 minutes, at which time you can then start modelling the restorations. FDA UDI
- Model / Reference
- 1186 FDA UDI
- Description
- This die silicone is an addition-curing silicone for the extraoral fabrication of dental models. Indirect composite restorations can be fabricated chairside on this silicone model. The die silicone’s special curing formula allows you ample time to apply the material. The material is fully cured after 4 minutes, at which time you can then start modelling the restorations. FDA UDI
Identifiers
- Catalog Number
- 1186 FDA UDI
- Primary DI / UDI-DI
- E22111861 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Polymer-based dental model material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polymer-based dental model material
die silicone by VOCO GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymer-based dental model material.
- Luminesse Shaded PMMA Discs — TALLADIUM, INC. · Class II
- Luminesse Shaded PMMA Discs — TALLADIUM, INC. · Class II
- Luminesse Shaded PMMA Discs — TALLADIUM, INC. · Class II
- Luminesse Shaded PMMA Discs — TALLADIUM, INC. · Class II
- Luminesse Multi-Layer PMMA Discs — TALLADIUM, INC. · Class II
- Luminesse Multi-Layer PMMA Discs — TALLADIUM, INC. · Class II
- Luminesse Multi-Layer PMMA Discs — TALLADIUM, INC. · Class II
- Luminesse Shaded PMMA Discs — TALLADIUM, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VOCO GmbH
Sources (1)
- FDA UDI da306840-6e84-4e2f-b301-1eabc15c1927 35 fields · synced May 30, 2026