Identity
- Trade Name
- Titan 5 95H10 FDA UDI
- Generic Name
- Dental bridge, metal-ceramic FDA UDI
- Device Name
- Content: 1 piece Height: 10 mm Titanium with toughness degree 5 (ASTM) for metal frameworks for veneering with ceramics as well as for bar and implant constructions FDA UDI
- Model / Reference
- MEAC0110 FDA UDI
- Description
- Content: 1 piece Height: 10 mm Titanium with toughness degree 5 (ASTM) for metal frameworks for veneering with ceramics as well as for bar and implant constructions FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800MEAC0110 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
Titan 5 95H10 by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental bridge, metal-ceramic.
- Prodent — Prodent Dental Technology (Shenzhen) Co., Ltd. · Class II
- Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
- STRAUMANN CARES SCREW RETAINED BARS/BRIDGE — Institut Straumann SA · Class II
- Base metal alloy — Institut Straumann SA · Class II
- Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- CAD/CAM Pontic Zirconia — Beijing Yingguan Dental Technology Co., Ltd. · N
- Base metal alloy — Institut Straumann SA · Class II
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
- Zirkonzahn GmbH
Sources (1)
- FDA UDI a6ec4ba5-4af5-4c4f-891a-bf672c958249 34 fields · synced May 30, 2026