Identity
- Trade Name
- 108.14SI BURNISHER XLStyle EUDAMEDPRODONT-HOLLIGER FDA UDI
- Generic Name
- Manual dental burnisher, reusable FDA UDI
- Device Name
- Brunissoir burnisher EUDAMEDburnisher dble n°14 bliss FDA UDI
- Model / Reference
- 108.14SI EUDAMEDFDA UDI
- Description
- burnisher dble n°14 bliss FDA UDI
Identifiers
- Catalog Number
- 108.14SI FDA UDI
- Primary DI / UDI-DI
- 03665224022251 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665224BURNISHERPT EUDAMED
- Direct Marketing DI
- 03665224022251 EUDAMED
- FDA Product Code
- EKJ FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Manual dental burnisher, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
108.14SI BURNISHER XLStyle by Prodont-Holliger — 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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3665224BURNISHERPT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Prodont-Holliger
- EUDAMED SRN
- FR-MF-000000956
Sources (2)
- EUDAMED 0fc4c2c1-2aa1-4caa-9303-92a2a12aa067 61 fields · synced Jul 10, 2026
- FDA UDI 374f24c1-d06f-43f2-9f75-b5cc0a2f5160 34 fields · synced May 30, 2026