Identity
- Trade Name
- BioSonic FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- S1 Piezo Tip - Periodontal FDA UDI
- Model / Reference
- USP3S FDA UDI
- Description
- S1 Piezo Tip - Periodontal FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661USP3S0 FDA UDI
- 510(k) Number
- K053555 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization 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
Similar devices
Also classified as Ultrasonic dental scaling/debridement system.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- TurboSENSOR™ — PARKELL, INC. · Class II
- DTE, WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- PIEZO Tip BE-2 — BONART CO., LTD. · Class II
- SONICflex prep crown plain No. 98 — KaVo Dental GmbH · Class I
- Baolai — Nanning Baolai Medical Instrument Co., Ltd. · Class II
- SONICflex 2003 L (Set) — KaVo Dental GmbH · Class II
Cleared under the same submission
K053555 also covers:
- Comfort-Sonic — Beyes Dental Canada Inc
- Comfort-Sonic — Beyes Dental Canada Inc
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- BioSonic — Coltene/Whaledent Inc.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
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 e6adba48-b3bd-481f-be36-8242c17de2cd 35 fields · synced Jun 9, 2026