Identity
- Trade Name
- TITANIT 5 95H18 FDA UDI
- Generic Name
- Dental bridge, metal-ceramic FDA UDI
- Device Name
- Content: 1 piece Height: 18 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged. FDA UDI
- Model / Reference
- MEAL9518 FDA UDI
- Description
- Content: 1 piece Height: 18 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800MEAL9518 FDA UDI
- FDA Product Code
- EJH FDA UDI
- GMDN Term
- Dental bridge, metal-ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3710 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
Yes
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, metal-ceramic
Titanit 5 95h18 by Zirkonzahn GmbH — 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
- Zirkonzahn GmbH
Sources (1)
- FDA UDI 772ffbc3-2d38-4401-bb8e-c664a1d2bf1f 34 fields · synced May 31, 2026