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Lip Hook(3pccs) AC0407

by Good Doctors Co., Ltd.

Lip Hook(3pccs) AC0407 is an endodontic apex locator (FDA unclassified; FDA product code LQY, Locator, Root Apex) made by Good Doctors Co., Ltd., cleared under FDA 510(k) K151274 on 4 Feb 2016 and listed in FDA GUDID since 23 Aug 2023 (UDI-DI 08800025400531), active as of 23 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 23 Oct 2026

Documents

510(k) K151274

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800025400531 UDI-DI Date23 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK151274 Date4 Feb 2016IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151274 decided 4 Feb 2016 Active
  • FDA GUDID UDI-DI 08800025400531 listed 23 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151274
  2. Listed FDA GUDID 08800025400531

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lip Hook(3pccs)
Generic name
Endodontic apex locator
Model / reference
AC0407
Primary DI / UDI-DI
08800025400531
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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Properties

  • Sterilise before use
  • Lot / batch number
Other properties (13, all answered No)