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LOCATOR F-Tx 10157-01

by Zest Anchors, LLC

Ref 10157-01

LOCATOR F-Tx 10157-01 is a Class I device made by Zest Anchors, LLC, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 08404811Z022ED) and listed in FDA GUDID since 7 Jul 2022 (UDI-DI 00840481125485), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08404811Z022ED Basic UDI-DI 00840481125485UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840481125485 UDI-DI Date7 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08404811Z022ED registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 00840481125485 listed 7 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840481125485
  2. Registered EUDAMED 08404811Z022ED

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
LOCATOR Fixed EUDAMED
LOCATOR F-Tx GUDID
Generic name
Dental precision attachment fitting/adjustment tool
Device name
Locator Fixed Removal Tool
Model / reference
10157-01
Primary DI / UDI-DI
00840481125485
Basic UDI-DI
08404811Z022ED
Direct marketing DI
00840481125485
FDA product code
NDP
EMDN code
Q010280 Prosthetic dentistry devices - accessories
GMDN term
Dental precision attachment fitting/adjustment tool
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under PROSTHETIC DENTISTRY DEVICES - ACCESSORIES.

Other devices from Zest Anchors, LLC

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)