Identity
- Trade Name
- Comfort-Sonic FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- Woodpecker: GK6, Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; from first/third quadrant to central incisor accessed buccally, then cleansing of front teeth, premolars and molars of the second/fourth quadrant, accessed palatally/lingually FDA UDI
- Model / Reference
- UL2218 FDA UDI
- Description
- Woodpecker: GK6, Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; from first/third quadrant to central incisor accessed buccally, then cleansing of front teeth, premolars and molars of the second/fourth quadrant, accessed palatally/lingually FDA UDI
Identifiers
- Catalog Number
- K-61 FDA UDI
- Primary DI / UDI-DI
- 00990010306691 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Ultrasonic dental scaling/debridement system
Comfort-Sonic by Beyes Dental Canada Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K053555 also covers:
- Comfort-Sonic — Beyes Dental Canada Inc
- BioSonic — Coltene/Whaledent 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 |
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Manufacturer
- Manufacturer
- Beyes Dental Canada Inc
Sources (1)
- FDA UDI 023262d8-def2-40cb-b006-c3e2ff8a6126 35 fields · synced Jun 1, 2026