Identity
- Trade Name
- Nobilium FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- NOBILDENT POST L A00 /30L FDA UDI
- Model / Reference
- NPLA0030L FDA UDI
- Description
- NOBILDENT POST L A00 /30L FDA UDI
Identifiers
- Primary DI / UDI-DI
- M482NPLA0030L0 FDA UDI
- 510(k) Number
- K101029 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 pre-fabricated teeth made of polymer-based material for mounting on dentures. These teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours. This device is not approved by the FDA.
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
- Mondial 8i, D4 / M, CE — Kulzer, Inc. · Class II
- Monarch — Wright Health Group , Ltd. · Class II
- Ref-Line — POLIDENT d.o.o. · Class II
Cleared under the same submission
K101029 also covers:
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
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
- Cmp Industries Llc
Sources (1)
- FDA UDI 7906cf30-a656-4528-b7c4-fba818861d63 34 fields · synced Jul 30, 2026