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Healing Abutment STHA457M

by Megagen Implant Co. Ltd

Ref STHA457M

Healing Abutment STHA457M 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 10 Jun 2026 (Basic UDI-DI 880972899110PL), cleared under FDA 510(k) K192347 on 14 Nov 2019 and listed in FDA GUDID since 27 Dec 2019 (UDI-DI 08806388248797), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192347

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899110PL Basic UDI-DI 08806388248797UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806388248797 UDI-DI Date27 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192347 Date14 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880972899110PL registered 10 Jun 2026 Active
  • FDA 510(k) K192347 decided 14 Nov 2019 Active
  • FDA GUDID UDI-DI 08806388248797 listed 27 Dec 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192347
  2. Listed FDA GUDID 08806388248797
  3. Registered EUDAMED 880972899110PL

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  • Withdrawn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, permanent, preformed
Model / Ref / Catalog
STHA457M
Primary DI / UDI-DI
08806388248797
Basic UDI-DI
880972899110PL
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
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 (K192347)

and 8 more cleared under K192347

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

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)