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Apex ID

by Meta Systems Co., Ltd. 6 variants

Ref 972-0094Model Apex ID

Apex ID (972-0094) is an endodontic apex locator (EU MDD Class IIa; FDA unclassified; FDA product code LQY, Locator, Root Apex) made by Meta Systems Co., Ltd., registered in EUDAMED on 31 Mar 2026 (Basic UDI-DI B-08809455602119), cleared under FDA 510(k) K112153 on 26 Apr 2012 and listed in FDA GUDID since 30 Dec 2024 (UDI-DI 08809455602119), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K112153

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809455602119 Basic UDI-DI 08809455602119UDI-DIDate31 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809455602119 UDI-DI Date30 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112153 Date26 Apr 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809455602119 registered 31 Mar 2026 Active
  • FDA 510(k) K112153 decided 26 Apr 2012 Active
  • FDA GUDID UDI-DI 08809455602119 listed 30 Dec 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K112153
  2. Listed FDA GUDID 08809455602119
  3. Registered EUDAMED B-08809455602119

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Endodontic apex locator
Model / Ref / Catalog
Apex ID, 972-0094, Apex ID File Holder A
Primary DI / UDI-DI
08809455602119
Basic UDI-DI
B-08809455602119
FDA product code
LQY
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Endodontic apex locator
Device class
Class IIa EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Apex ID
972-0094
GUDID
Apex ID File Holder A
Device classEUDAMED
Class IIa
GUDID
U

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000022945
Authorised representative
Meta Biomed Europe GmbH DE-AR-000004953

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Meta Systems Co., Ltd.

See all devices from Meta Systems Co., Ltd. →

Properties

  • Sterilise before use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)