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Locator® 08917-2

by Zest Anchors, LLC

Ref 08917-2

Locator® 08917-2 is a device classified as Class IIa in the EU and Class II in the US made by Zest Anchors, LLC, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 08404811Z004EB) and listed in FDA GUDID since 26 Mar 2022 (UDI-DI 00840481108938), 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 Number08404811Z004EB Basic UDI-DI 00840481108938UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840481108938 UDI-DI Date26 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08404811Z004EB registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 00840481108938 listed 26 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840481108938
  2. Registered EUDAMED 08404811Z004EB

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  • Withdrawn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, permanent, preformed
Device name
Locator Abutment - Multiunit
Model / reference
08917-2
Primary DI / UDI-DI
00840481108938
Basic UDI-DI
08404811Z004EB
FDA product code
NHA
EMDN code
Q01020602 Combined dental prostheses
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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

Related devices

Category: Dental implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under DENTAL PROSTHESES (FOR DENTAL IMPLANTS SEE P010201).

Other devices from Zest Anchors, LLC

See all devices from Zest Anchors, LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)