Identity
- Trade Name
- neo.lign P tooth FDA UDI
- Generic Name
- Custom-made dental crown, metal/ceramic FDA UDI
- Device Name
- neo.lign P tooth posterior 1G3 upper A20 4 parts (14,15,16,17) 1 Assortment FDA UDI
- Model / Reference
- TO1G3A20 FDA UDI
- Description
- neo.lign P tooth posterior 1G3 upper A20 4 parts (14,15,16,17) 1 Assortment FDA UDI
Identifiers
- Catalog Number
- TO1G3A20 FDA UDI
- Primary DI / UDI-DI
- EBRETO1G3A200 FDA UDI
- FDA Product Code
- ELM FDA UDI
- GMDN Term
- Custom-made dental crown, metal/ceramic 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: Custom-made dental crown, metal/ceramic
neo.lign P tooth by bredent GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- bredent GmbH & Co. KG
Sources (1)
- FDA UDI e975c918-f6be-4990-8923-10eb67ea6d3a 35 fields · synced Jun 8, 2026