Identity
- Trade Name
- Ortho Veneer System FDA UDI
- Generic Name
- Custom-made dental composite resin kit FDA UDI
- Device Name
- OVS is intended for use as a composite system for the fabrication of veneers on undersized teeth. The kit contains 1 X 3cc Light Bond Sealant, 1 X 2.5g Ortho Veneer paste shade B-1, 1 X 2.5g Ortho Veneer shade A-1, 1 X 2.5g Ortho Veneer shade A-2, (5 Medium and 5 Large) Faci Forms Crown Form #12, (5 Medium and 5 Large) Faci Forms Crown Form #22, 1 X (16) Stick and Place instruments FDA UDI
- Model / Reference
- OVS FDA UDI
- Description
- OVS is intended for use as a composite system for the fabrication of veneers on undersized teeth. The kit contains 1 X 3cc Light Bond Sealant, 1 X 2.5g Ortho Veneer paste shade B-1, 1 X 2.5g Ortho Veneer shade A-1, 1 X 2.5g Ortho Veneer shade A-2, (5 Medium and 5 Large) Faci Forms Crown Form #12, (5 Medium and 5 Large) Faci Forms Crown Form #22, 1 X (16) Stick and Place instruments FDA UDI
Identifiers
- Catalog Number
- OVS FDA UDI
- Primary DI / UDI-DI
- D798OVS0 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Custom-made dental composite resin kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Custom-made dental composite resin kit
Ortho Veneer System by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made dental composite resin kit.
- inspiro Skin Bleach — EDELWEISS DR ag · Class II
- inspiro Intro Kit Syringe — EDELWEISS DR ag · Class II
- inspiro Body i4 — EDELWEISS DR ag · Class II
- inspiro Mini Kit Esthetic Anterior — EDELWEISS DR ag
- inspiro Skin White — EDELWEISS DR ag · Class II
- CAMouflage — PRISMATIK DENTALCRAFT, INC. · Class II
- inspiro Body i0 — EDELWEISS DR ag · Class II
- inspiro Skin Ivory — EDELWEISS DR ag · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI cb484a44-ebd5-4208-8022-a84f2e0e1ee1 36 fields · synced Jun 1, 2026