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Locator® 08515

by Zest Anchors, LLC

Ref 08515

Locator® 08515 is a Class I device made by Zest Anchors, LLC, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 08404811Z073EW) and listed in FDA GUDID since 26 Mar 2022 (UDI-DI 00840481127632), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08404811Z073EW Basic UDI-DI 00840481127632UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840481127632 UDI-DI Date26 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08404811Z073EW registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 00840481127632 listed 26 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840481127632
  2. Registered EUDAMED 08404811Z073EW

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  • Withdrawn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 EUDAMED
Locator® GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
LOCATOR Processing Insert
Model / reference
08515
Primary DI / UDI-DI
00840481127632
Basic UDI-DI
08404811Z073EW
FDA product code
EGG
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class I
Regulation number
872.3165
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
High-level Disinfectant

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Dental implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Zest Anchors, LLC

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Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)