Dte, Woodpecker PD43L
by Guilin Woodpecker Medical Instrument Co., Ltd.
Dte, Woodpecker PD43L is an ultrasonic dental scaling/debridement system (FDA Class II; FDA product code ELC, Scaler, Ultrasonic) made by Guilin Woodpecker Medical Instrument Co., Ltd., cleared under FDA 510(k) K053555 on 21 Aug 2006 and listed in FDA GUDID since 19 Aug 2022 (UDI-DI 06944843605517), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06944843605517 | Date19 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053555 | Date21 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 06944843605517
- FDA 510(k) database K053555
Across registries
- FDA 510(k) K053555 decided 21 Aug 2006 Active
- FDA GUDID UDI-DI 06944843605517 listed 19 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K053555
- Listed FDA GUDID 06944843605517
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dte,woodpecker
- Generic name
- Ultrasonic dental scaling/debridement system
- Model / reference
- PD43L
- Primary DI / UDI-DI
- 06944843605517
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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