Identity
- Trade Name
- BONARTIC II NFCplus FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Model / Reference
- 643074 FDA UDI
Identifiers
- Catalog Number
- 643074 FDA UDI
- Primary DI / UDI-DI
- E1996430741 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
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
Yes
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
BONARTIC II NFCplus by Candulor AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Resin artificial teeth.
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- artegral life — Merz Dental GmbH · Class II
- Mondial 8i, D4 / M, CE — Kulzer, Inc. · Class II
- Monarch — Wright Health Group , Ltd. · Class II
- Ref-Line — POLIDENT d.o.o. · Class II
- artegral life — Merz Dental GmbH · Class II
- Resin Teeth DCL PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · 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
- Candulor AG
Sources (1)
- FDA UDI ba82373a-6ed6-4ca0-a911-690c0174d177 33 fields · synced May 31, 2026