Identity
- Trade Name
- WOODPECKER FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
- Device Name
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
- Model / Reference
- HW-3L FDA UDI
- Description
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843603735 FDA UDI
- 510(k) Number
- K053555 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece 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
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement system handpiece
Woodpecker by Guilin Woodpecker Medical Instrument Co., Ltd. — 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
- 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.
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
- Guilin Woodpecker Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI cf82f1dc-a8bf-4939-811a-01dfd25566c0 34 fields · synced Jun 6, 2026