Identity
- Trade Name
- BioSonic FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- SUVI Premier Ultrasonic Scaler FDA UDI
- Model / Reference
- 60014245 FDA UDI
- Description
- SUVI Premier Ultrasonic Scaler FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661600142450 FDA UDI
- 510(k) Number
- K130137 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Ultrasonic dental scaling/debridement system
BioSonic by Coltene/Whaledent Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130137 also covers:
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI 24570de0-36d7-4335-9102-74e2ba284fa1 36 fields · synced Jun 9, 2026