Identity
- Trade Name
- 408.05SI scaler double gfx 21 xl EUDAMEDPRODONT-HOLLIGER FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- curettes EUDAMEDcurette barnhart 5-6 bliss FDA UDI
- Model / Reference
- 408.05SI EUDAMEDFDA UDI
- Description
- curette barnhart 5-6 bliss FDA UDI
Identifiers
- Catalog Number
- 408.05SI FDA UDI
- Primary DI / UDI-DI
- 03665224022206 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665224CURETTESDETARTRUW EUDAMED
- Direct Marketing DI
- 03665224022206 EUDAMED
- FDA Product Code
- EMS FDA UDI
- EMDN Code
- L159001 DENTAL AND PERIODONTAL CURETTES, REUSABLE EUDAMED
- GMDN Term
- Periodontal curette 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
408.05SI scaler double gfx 21 xl 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 | 3665224CURETTESDETARTRUW | 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 a9f1ce6e-ba06-44db-a630-ae72997f878f 61 fields · synced Jul 18, 2026
- FDA UDI 118b1468-3160-4ac1-81fc-ad3f83a0fbfa 34 fields · synced May 30, 2026