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Dte PD22L

by Guilin Woodpecker Medical Instrument Co., Ltd.

Dte PD22L is a Class II device made by Guilin Woodpecker Medical Instrument Co., Ltd., cleared under FDA 510(k) K053555 on 21 Aug 2006 and listed in FDA GUDID since 27 Jan 2018 (UDI-DI 06944843600765), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K053555

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06944843600765 UDI-DI Date27 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK053555 Date21 Aug 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K053555 decided 21 Aug 2006 Active
  • FDA GUDID UDI-DI 06944843600765 listed 27 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K053555
  2. Listed FDA GUDID 06944843600765

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dte
Generic name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / reference
PD22L
Primary DI / UDI-DI
06944843600765
510(k) Number
FDA product code
ELC
GMDN term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Device class
Class II
Regulation number
872.4850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Guilin Woodpecker Medical Instrument Co., Ltd.

See all devices from Guilin Woodpecker Medical Instrument Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Serial number
Other properties (12, all answered No)