Identity
- Trade Name
- Faci Form FDA UDI
- Generic Name
- Dental veneer, professional FDA UDI
- Device Name
- Faci Forms are intended for use as a mold for the creation of temporary, prosthetic composite teeth. This is a pack of 5 medium and 5 large for the left side of the arch. Size #12. FDA UDI
- Model / Reference
- FFL FDA UDI
- Description
- Faci Forms are intended for use as a mold for the creation of temporary, prosthetic composite teeth. This is a pack of 5 medium and 5 large for the left side of the arch. Size #12. FDA UDI
Identifiers
- Catalog Number
- FFL FDA UDI
- Primary DI / UDI-DI
- D798FFL0 FDA UDI
- FDA Product Code
- ECP FDA UDI
- GMDN Term
- Dental veneer, professional FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental veneer, professional
Faci Form by Reliance Orthodontic Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental veneer, professional.
- crea.lign Dentin A2 — bredent GmbH & Co. KG · Class II
- crea.lign incisal E1 — bredent GmbH & Co. KG · Class II
- COMPONEER BRILLIANT — Coltène/Whaledent AG · Class II
- COMPONEER — Coltène/Whaledent AG · Class II
- COMPONEER BRILLIANT — Coltène/Whaledent AG · Class II
- COMPONEER — Coltène/Whaledent AG · Class II
- BRILLIANT NG — Coltène/Whaledent AG · Class II
- Ceramill — Vertex-Dental B.V. · Class I
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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 627f5a2a-8a21-49aa-89fc-bac196de742b 36 fields · synced May 30, 2026