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Healing Abutment HA4006GR

by ARUM DENTISTRY Co., Ltd.

Part of a family of 150 devices: see the family page

Ref HA4006GR

Healing Abutment HA4006GR is a device classified as Class IIb in the EU and Class II in the US made by ARUM DENTISTRY Co., Ltd., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 88000557HAAP), cleared under FDA 510(k) K222131 on 19 Sep 2022 and listed in FDA GUDID since 29 Mar 2023 (UDI-DI 08809917604125), 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) K222131

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 Number88000557HAAP Basic UDI-DI 08809917604125UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809917604125 UDI-DI Date29 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK222131 Date19 Sep 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000557HAAP registered 28 May 2026 Active
  • FDA 510(k) K222131 decided 19 Sep 2022 Active
  • FDA GUDID UDI-DI 08809917604125 listed 29 Mar 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222131
  2. Listed FDA GUDID 08809917604125
  3. Registered EUDAMED 88000557HAAP

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  • Withdrawn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
Healing Abutment
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
Dental Healing Abutment
Model / reference
HA4006GR
Primary DI / UDI-DI
08809917604125
Basic UDI-DI
88000557HAAP
510(k) Number
FDA product code
DZE, NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640, 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

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

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

  • Supplied sterile UDI-DI 08809917604125: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 08809917604125: EUDAMED states No, FDA GUDID states Yes.

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

Cleared under the same submission (K222131)

and 8 more cleared under K222131

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from ARUM DENTISTRY Co., Ltd.

See all devices from ARUM DENTISTRY Co., Ltd. →

Properties

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