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Angled Abutment (Hex) HISA45115

by InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

Ref HISA45115

Angled Abutment (Hex) HISA45115 is a device classified as Class IIb in the EU and Class II in the US made by InnoBioSurg Co., Ltd(IBS implant Co., Ltd), registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08800039305082), cleared under FDA 510(k) K153350 on 9 May 2016 and listed in FDA GUDID since 16 Nov 2018 (UDI-DI 08800039305082), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153350

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800039305082 Basic UDI-DI 08800039305082UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800039305082 UDI-DI Date16 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153350 Date9 May 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800039305082 registered 6 Nov 2026 Active
  • FDA 510(k) K153350 decided 9 May 2016 Active
  • FDA GUDID UDI-DI 08800039305082 listed 16 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153350
  2. Listed FDA GUDID 08800039305082
  3. Registered EUDAMED B-08800039305082

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Magicore EUDAMED
Angled Abutment (Hex) GUDID
Generic name
Dental implant system
Device name
Angled Abutment
Model / reference
HISA45115
Primary DI / UDI-DI
08800039305082
Basic UDI-DI
B-08800039305082
510(k) Number
FDA product code
NHA, DZE
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630, 872.3640
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

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

  • Supplied sterile UDI-DI 08800039305082: EUDAMED states Yes, FDA GUDID states No.

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 system

Cleared under the same submission (K153350)

and 8 more cleared under K153350

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

See all devices from InnoBioSurg Co., Ltd(IBS implant Co., Ltd) →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Single use
  • Implantable
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)