Identity
- Trade Name
- DTS, RESTORATION, PORCELAIN-FUSED FDA UDI
- Generic Name
- Dental bridge, metal-ceramic FDA UDI
- Model / Reference
- Porcelain Fused to FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977512700084 FDA UDI
- FDA Product Code
- NSO FDA UDI
- GMDN Term
- Dental bridge, metal-ceramic FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental bridge, metal-ceramic
Dts, Restoration, Porcelain-Fused by DTS Digital Dental Lab — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental bridge, metal-ceramic.
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- Sintermetall 98H14 — Zirkonzahn GmbH · Class II
- 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
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 N | Pending data |
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Manufacturer
- Manufacturer
- DTS Digital Dental Lab
Sources (1)
- FDA UDI 0dff6e35-a416-4b48-a8d1-32051539381a 32 fields · synced Jun 6, 2026