Identity
- Trade Name
- neo.lign A tooth FDA UDI
- Generic Name
- Custom-made dental crown, metal/ceramic FDA UDI
- Device Name
- neo.lign A tooth anterior I45 upper A20 6 parts (13,12,11,21,22,23) 1 Assortment FDA UDI
- Model / Reference
- TOI45A20S FDA UDI
- Description
- neo.lign A tooth anterior I45 upper A20 6 parts (13,12,11,21,22,23) 1 Assortment FDA UDI
Identifiers
- Catalog Number
- TOI45A20S FDA UDI
- Primary DI / UDI-DI
- EBRETOI45A20S0 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 A tooth by bredent GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made dental crown, metal/ceramic.
- Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
- Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- PFM Crown Co Cr (NP) — Beijing Yingguan Dental Technology Co., Ltd. · N
- Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
- Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
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
- bredent GmbH & Co. KG
Sources (1)
- FDA UDI 3adcee53-32fc-4b40-93b5-2e6a7419c661 35 fields · synced May 30, 2026