Identity
- Trade Name
- Resin Teeth DCL PE FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- SR Vivodent 6er OA13 530 FDA UDI
- Model / Reference
- 540941 FDA UDI
- Description
- SR Vivodent 6er OA13 530 FDA UDI
Identifiers
- Catalog Number
- 540941 FDA UDI
- Primary DI / UDI-DI
- DIVO5409411 FDA UDI
- FDA Product Code
- ELM FDA UDI
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3590 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Resin artificial teeth
A comprehensive resin artificial teeth device used for mounting on dentures, suitable for various sizes, shapes and colours. It's a prefabricated tooth made of polymer-based material, designed for implantable use.
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Also classified as Resin artificial teeth.
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- Ref-Line — POLIDENT d.o.o. · Class II
- artegral life — Merz Dental GmbH · 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 |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI 32864a54-4a2e-421f-b4cf-2bc581879e1e 34 fields · synced Jul 22, 2026