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Medidenta COMPEX

by Guilin Woodpecker Medical Instrument Co., Ltd.

Medidenta COMPEX is a device classified as Unclassified made by Guilin Woodpecker Medical Instrument Co., Ltd., cleared under FDA 510(k) K181087 on 18 Dec 2018 and listed in FDA GUDID since 25 Aug 2021 (UDI-DI 06944843605579), 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) K181087

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 Number06944843605579 UDI-DI Date25 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181087 Date18 Dec 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181087 decided 18 Dec 2018 Active
  • FDA GUDID UDI-DI 06944843605579 listed 25 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181087
  2. Listed FDA GUDID 06944843605579

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medidenta
Generic name
Endodontic apex locator
Model / reference
COMPEX
Primary DI / UDI-DI
06944843605579
510(k) Number
FDA product code
LQY
GMDN term
Endodontic apex locator
Device class
U
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under Endodontic apex locator.

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Properties

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