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Octa Abutment AROOAR5030

by Megagen Implant Co. Ltd

Part of a family of 49 devices: see the family page

Ref AROOAR5030

Octa Abutment AROOAR5030 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 17 Jul 2026 (Basic UDI-DI 880972899893M), cleared under FDA 510(k) K182448 on 9 Oct 2019 and listed in FDA GUDID since 21 Nov 2019 (UDI-DI 08806388256518), 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) K182448

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 Number880972899893M Basic UDI-DI 08806388256518UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806388256518 UDI-DI Date21 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182448 Date9 Oct 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880972899893M registered 17 Jul 2026 Active
  • FDA 510(k) K182448 decided 9 Oct 2019 Active
  • FDA GUDID UDI-DI 08806388256518 listed 21 Nov 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182448
  2. Listed FDA GUDID 08806388256518
  3. Registered EUDAMED 880972899893M

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  • Withdrawn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
Octa Abutment
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
AROOAR5030
Primary DI / UDI-DI
08806388256518
Basic UDI-DI
880972899893M
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
MRI safety
MR Conditional

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

Cleared under the same submission (K182448)

and 8 more cleared under K182448

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

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)