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Locator 08016

by Zest Anchors, LLC

Part of a family of 8 devices: see the family page

Ref 08016

Locator 08016 is a Class I device made by Zest Anchors, LLC, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 08404811Z009EM) and listed in FDA GUDID since 8 Jul 2022 (UDI-DI 00840481100970), 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 Number08404811Z009EM Basic UDI-DI 00840481100970UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840481100970 UDI-DI Date8 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08404811Z009EM registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 00840481100970 listed 8 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840481100970
  2. Registered EUDAMED 08404811Z009EM

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  • Withdrawn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
Generic name
Fluted surgical drill bit, reusable
Device name
Locator Bar Ancillary Devices (Tools)
Model / reference
08016
Primary DI / UDI-DI
00840481100970
Basic UDI-DI
08404811Z009EM
Direct marketing DI
00840481100970
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Fluted surgical drill bit, reusable
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 drill guide, reusable

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Zest Anchors, LLC

See all devices from Zest Anchors, LLC →

Properties

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