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Locator 08954

by Zest Anchors, LLC

Part of a family of 1,229 devices: see the family page

Ref 08954

Locator 08954 is a device classified as Class IIb in the EU and Class II in the US made by Zest Anchors, LLC, registered in EUDAMED on 30 Apr 2026 (Basic UDI-DI 08404811Z005ED) and listed in FDA GUDID since 15 Dec 2016 (UDI-DI 00840481100093), 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 Number08404811Z005ED Basic UDI-DI 00840481100093UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840481100093 UDI-DI Date15 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08404811Z005ED registered 30 Apr 2026 Active
  • FDA GUDID UDI-DI 00840481100093 listed 15 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840481100093
  2. Registered EUDAMED 08404811Z005ED

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  • Withdrawn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
Dental implant suprastructure, permanent, preformed
Device name
Locator Abutment - Standard
Model / Ref / Catalog
08954
Primary DI / UDI-DI
00840481100093
Basic UDI-DI
08404811Z005ED
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb 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
Size
Length — 5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 IMPLANTS - ACCESSORIES.

Other devices from Zest Anchors, LLC

See all devices from Zest Anchors, LLC →

Properties

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