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Ankylos® 31036530

by Dentsply Implants Manufacturing GmbH

Ref 31036530

Ankylos® 31036530 is a device classified as Class IIa in the EU and Class I in the US made by Dentsply Implants Manufacturing GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 739253200077DE) and listed in FDA GUDID since 14 Jul 2022 (UDI-DI 07392532219689), 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 Number739253200077DE Basic UDI-DI 07392532219689UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532219689 UDI-DI Date14 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 739253200077DE registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 07392532219689 listed 14 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07392532219689
  2. Registered EUDAMED 739253200077DE

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  • Withdrawn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® Surgical Kit Guided Surgery EUDAMED
Ankylos® GUDID
Generic name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device name
Ankylos Surgical Instruments IIa Filled Trays
Model / Ref / Catalog
31036530
Primary DI / UDI-DI
07392532219689
Basic UDI-DI
739253200077DE
Direct marketing DI
07392532275128
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07392532219689: EUDAMED states Yes, FDA GUDID states No.

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

Related devices

Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Dentsply Implants Manufacturing GmbH

See all devices from Dentsply Implants Manufacturing GmbH →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)