Identity
- Trade Name
- DTS EUDAMEDDTS, RESTORATION, PORCELAIN FDA UDI
- Generic Name
- Dental bridge, ceramic FDA UDI
- Device Name
- RESTORATION, PORCELAIN EUDAMED
- Model / Reference
- All-ceramic Crown/Bridge EUDAMEDFDA UDI501030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977512700008 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06977512700008 EUDAMED
- FDA Product Code
- NSP FDA UDI
- EMDN Code
- Q01020602,Q01020605 EUDAMED
- GMDN Term
- Dental bridge, ceramic FDA UDI
Classification
- Device Class
- Class I EUDAMEDN FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dts by Dts Digital Dental Lab — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06977512700008 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DTS Digital Dental Lab
- EUDAMED SRN
- CN-MF-000044230
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 3cbc85ae-522c-463c-859a-c885db800bfb 61 fields · synced May 30, 2026
- FDA UDI c63caf85-12ff-4e18-af36-245b324df87e 32 fields · synced May 30, 2026