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Henry Schein 5701441

by Henry Schein, Inc.

Henry Schein 5701441 is a device classified as Unclassified made by Henry Schein, Inc., cleared under FDA 510(k) K181087 on 18 Dec 2018 and listed in FDA GUDID since 28 Mar 2019 (UDI-DI 10304040110598), 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) K181087

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 Number10304040110598 UDI-DI Date28 Mar 2019ListedStatusListed 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 10304040110598 listed 28 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181087
  2. Listed FDA GUDID 10304040110598

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Henry Schein
Generic name
Endodontic apex locator
Model / Ref / Catalog
5701441
Primary DI / UDI-DI
10304040110598
510(k) Number
FDA product code
LQY
GMDN term
Endodontic apex locator
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endodontic apex locator

Cleared under the same submission (K181087)

and 8 more cleared under K181087

Similar devices in this category

Other devices filed under Endodontic apex locator.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

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