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Dte, Woodpecker UL22

by Guilin Woodpecker Medical Instrument Co., Ltd.

Dte, Woodpecker UL22 is a dental ultrasonic surgical system (FDA Class II) made by Guilin Woodpecker Medical Instrument Co., Ltd., cleared under FDA 510(k) K111290 on 18 Nov 2011 and listed in FDA GUDID since 17 Aug 2022 (UDI-DI 06944843605159), 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) K111290

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 Number06944843605159 UDI-DI Date17 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111290 Date18 Nov 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111290 decided 18 Nov 2011 Active
  • FDA GUDID UDI-DI 06944843605159 listed 17 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K111290
  2. Listed FDA GUDID 06944843605159

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dte,woodpecker
Generic name
Dental ultrasonic surgical system
Model / reference
UL22
Primary DI / UDI-DI
06944843605159
510(k) Number
FDA product code
DZI, ELC
GMDN term
Dental ultrasonic surgical system
Device class
Class II
Regulation number
872.4120, 872.4850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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

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Properties

  • Sterilise before use
  • Prescription use
  • Manufacturing date
Other properties (12, all answered No)