Identity
- Trade Name
- TRIBOS 501 Kunststoffzähne EUDAMEDNA FDA UDI
- Generic Name
- Partial denture FDA UDI
- Device Name
- TRIBOS 501 Kunststoffzähne SM-OK-C4 EUDAMEDTRIBOS 501 Kunststoffzaehne SM-OK-C4 FDA UDI
- Model / Reference
- 21013 EUDAMEDFDA UDI
- Description
- TRIBOS 501 Kunststoffzaehne SM-OK-C4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- +EGEB21013 EUDAMEDEGEB210131 FDA UDI
- Basic UDI-DI
- B-+EGEB21013 EUDAMED
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
- GMDN Term
- Partial denture FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Partial denture
TRIBOS 501 Kunststoffzähne by Gebdi Dental-Products GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-+EGEB21013 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- gebdi DENTAL-PRODUCTS GmbH
- EUDAMED SRN
- DE-MF-000005566
Sources (2)
- EUDAMED 48fc6221-cb19-4a8c-99b3-b96a70f4abf3 61 fields · synced Jun 19, 2026
- FDA UDI b9c616da-e0d5-4418-97ae-c60179879b75 34 fields · synced May 24, 2026