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DTE i-Polish

by Guilin Woodpecker Medical Instrument Co., Ltd.

DTE i-Polish is a Class I device made by Guilin Woodpecker Medical Instrument Co., Ltd., cleared under FDA 510(k) K211531 on 17 Dec 2021 and listed in FDA GUDID since 18 Oct 2024 (UDI-DI 06944843657721), 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) K211531

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 Number06944843657721 UDI-DI Date18 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211531 Date17 Dec 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211531 decided 17 Dec 2021 Active
  • FDA GUDID UDI-DI 06944843657721 listed 18 Oct 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211531
  2. Listed FDA GUDID 06944843657721

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  • Withdrawn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
Dental surgical power tool motorized handpiece/set, electric
Model / reference
i-Polish
Primary DI / UDI-DI
06944843657721
510(k) Number
FDA product code
EKX
GMDN term
Dental surgical power tool motorized handpiece/set, electric
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental surgical power tool motorized handpiece/set, electric

Cleared under the same submission (K211531)

and 8 more cleared under K211531

Similar devices in this category

Other devices filed under Dental surgical power tool motorized handpiece/set, electric.

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

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

Properties

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