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AnyRidge Internal ARNEEN5045

by Megagen Implant Co. Ltd

Ref ARNEEN5045L

AnyRidge Internal ARNEEN5045 (ARNEEN5045L) is a device classified as Class IIb in the EU and Class II in the US made by Megagen Implant Co. Ltd, registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI 880972899193QJ), cleared under FDA 510(k) K110955 on 22 Nov 2011 and listed in FDA GUDID since 22 Sep 2023 (UDI-DI 08806388261635), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K110955

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899193QJ Basic UDI-DI 08806388261635UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806388261635 UDI-DI Date22 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK110955 Date22 Nov 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880972899193QJ registered 13 Jul 2026 Active
  • FDA 510(k) K110955 decided 22 Nov 2011 Active
  • FDA GUDID UDI-DI 08806388261635 listed 22 Sep 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K110955
  2. Listed FDA GUDID 08806388261635
  3. Registered EUDAMED 880972899193QJ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
AnyRidge Internal
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Extra EZ Post Abutment
Model / Ref / Catalog
ARNEEN5045L, ARNEEN5045
Primary DI / UDI-DI
08806388261635
Basic UDI-DI
880972899193QJ
510(k) Number
FDA product code
NHA
EMDN code
P01020101 Dental implants
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
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ARNEEN5045L
GUDID
ARNEEN5045
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K110955)

and 8 more cleared under K110955

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

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