Identity
- Trade Name
- Anatomic Coloured A2 95H14 FDA UDI
- Generic Name
- Dental bridge, ceramic FDA UDI
- Device Name
- Content: 1 piece, Height: 14 mm, Pre-coloured zirconia for single crowns, inlays, onlays, veneers, full-contour bridges (fully anatomic structures or reduced structures for veneering with ceramics) FDA UDI
- Model / Reference
- ZRHB8021A02 FDA UDI
- Description
- Content: 1 piece, Height: 14 mm, Pre-coloured zirconia for single crowns, inlays, onlays, veneers, full-contour bridges (fully anatomic structures or reduced structures for veneering with ceramics) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800ZRHB8021A02 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental bridge, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 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
Yes
FDA UDI
Category: Dental bridge, ceramic
Welcome to the Anatomic Coloured A2 95H14 medical device directory. This comprehensive guide provides detailed information about this innovative dental implant solution, including its features, compliance status, and FAQs.
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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
- Zirkonzahn GmbH
Sources (1)
- FDA UDI d6ed327c-26f6-4ef4-9562-c560ce1c9e51 34 fields · synced Jul 22, 2026