Identity
- Trade Name
- BioSonic Ultrasonic Scaler CE EUDAMEDBioSonic FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- BioSonic US100R Ultrasonic Scaler EUDAMEDBioSonic Ultrasonic Scaler, 230V FDA UDI
- Model / Reference
- US100R230CE EUDAMEDFDA UDI
- Description
- BioSonic Ultrasonic Scaler, 230V FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661US100R230CE0 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661US100R230CE0 EUDAMED
- 510(k) Number
- K983727 FDA UDI
- FDA Product Code
- ELC FDA UDI
- EMDN Code
- L159009 ODONTOSTOMATOLOGY SCALERS, REUSABLE EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BioSonic Ultrasonic Scaler CE by Coltene/Whaledent Inc. — Class IIa — 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-D661US100R230CE0 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED e65fd9a4-d245-4377-b012-bb1e7fbfc70a 61 fields · synced Jun 18, 2026
- FDA UDI 1294c2b4-2c16-4af0-8ee8-b65f8c01a3c0 35 fields · synced May 30, 2026