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Ankylos® 31010481

by Dentsply Implants Manufacturing GmbH

Ref 31010481

Ankylos® 31010481 is a device classified as Class IIb in the EU and Class II in the US made by Dentsply Implants Manufacturing GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 739253200095DG) and listed in FDA GUDID since 18 Nov 2020 (UDI-DI 07392532206023), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number739253200095DG Basic UDI-DI 07392532206023UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532206023 UDI-DI Date18 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 739253200095DG registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 07392532206023 listed 18 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07392532206023
  2. Registered EUDAMED 739253200095DG

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  • Withdrawn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
ANKYLOS® C/X Cover Screw 1mm EUDAMED
Ankylos® GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
Ankylos Tissue Management IIb Healing components
Model / Ref / Catalog
31010481
Primary DI / UDI-DI
07392532206023
Basic UDI-DI
739253200095DG
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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, temporary, preformed, single-use

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Dentsply Implants Manufacturing GmbH

See all devices from Dentsply Implants Manufacturing GmbH →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)