Identity
- Trade Name
- tria-shine combi-pack EUDAMEDTria-shine combi pack FDA UDI
- Generic Name
- Dental abrasive strip, single-use FDA UDI
- Device Name
- DENTAL ABRASIVES EUDAMED
- Model / Reference
- 5507 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +E29955070 EUDAMEDE29955070 FDA UDI
- Basic UDI-DI
- ++E299DENTALABRASIVESGD EUDAMED
- FDA Product Code
- EHL FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive strip, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Liechtenstein 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
tria-shine combi-pack by Polydentia SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E299DENTALABRASIVESGD | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++E299DENTALABRASIVESGD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-MF-000008779
- Authorised Representative
- IDD International Dental Distributors AG LI-AR-000008367
Sources (2)
- EUDAMED bfba34f8-2ea1-47bc-a956-c6fee70f2a17 61 fields · synced May 31, 2026
- FDA UDI f60d5b3d-14e4-4f9f-999d-1448afee3804 33 fields · synced May 27, 2026