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Device Explorer · FDA GUDID · GMDN 16355

Endodontic apex locator

A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.

US‑registered devices171in commercial distribution
Companies24labelers on GUDID
Single‑use6%of device records
Sterile0%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Forum Engineering Technologies (96) Ltd.2313%
Meta Systems Co., Ltd.2112%
Guilin Woodpecker Medical Instrument Co., Ltd.169%
Beyes Dental Canada Inc169%
Patterson Dental Supply, Inc.95%
Osada Electric Co.,Ltd.85%
Schlumbohm Gmbh & Co. Kg85%
Hsg-S Corp.85%

Top labelers

CompanyDevicesShare
Forum Engineering Technologies (96) Ltd.2313%
Meta Systems Co., Ltd.2112%
Guilin Woodpecker Medical Instrument Co., Ltd.169%
Beyes Dental Canada Inc169%
Patterson Dental Supply, Inc.95%
Osada Electric Co.,Ltd.85%
Schlumbohm Gmbh & Co. Kg85%
Hsg-S Corp.85%
Vdw Gmbh74%
Peter Brasseler Holdings, Llc74%
Coltene/Whaledent Inc74%
Us Endodontics, Llc64%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Endo-Eze FindWirelexDetectRomiApexCanal-ProBingo-ProNovApexJAS PexCOXOROGINDTEEDEGENDOWOODPECKERWOODPECKER,DTEMedidentaNIC or SUPERLINE

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LQYLocator, Root Apex137
LQYLocator, root apex37
EKXHandpiece, Direct Drive, Ac-Powered7
EKXHandpiece, direct drive, ac-powered6
EKRPlugger, Root Canal, Endodontic5
EATTester, Pulp3

GMDN & GCC registration

  • GMDN code 16355 · non‑implantable
  • Single‑use 6% · sterile 0% · Rx‑only 79% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many endodontic apex locator products are registered in the US?

171 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endodontic apex locator", from 24 companies. The largest labeler is Forum Engineering Technologies (96) Ltd. with 13% of records.

Which FDA product codes apply?

LQY (Locator, Root Apex), LQY (Locator, root apex), EKX (Handpiece, Direct Drive, Ac-Powered), EKX (Handpiece, direct drive, ac-powered)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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