Identity
- Trade Name
- Mondial 6, D3 / T435, CE FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Denture, plastic, teeth FDA UDI
- Model / Reference
- 66975642 FDA UDI
- Description
- Denture, plastic, teeth FDA UDI
Identifiers
- Catalog Number
- 66975642 FDA UDI
- Primary DI / UDI-DI
- J014669756420 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
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 medical device directory listing the Mondial 6, D3 / T435, CE for denture and plastic teeth.
Similar devices
Also classified as Resin artificial teeth.
- Resin Teeth / DCL / PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
- Candulor NFC+ — Candulor AG · Class II
- Physioset TCR 6er — Candulor AG · Class II
- Portrait® IPN® Anteriors — Dentsply International · Class II
- artegral life — Merz Dental GmbH · Class II
- Monarch — Wright Health Group , Ltd. · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA UDI e21091f8-2dc1-41a8-b335-f5c971c2c0e5 35 fields · synced Jul 31, 2026