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Magicore Narrow 401M3515

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

Ref 401M3515

Magicore Narrow 401M3515 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 5 Nov 2026 (Basic UDI-DI B-08800039363716), cleared under FDA 510(k) K220517 on 20 Dec 2022 (1 earlier submission) and listed in FDA GUDID since 3 Jan 2023 (UDI-DI 08800039363716), 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) K220517

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800039363716 Basic UDI-DI 08800039363716UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800039363716 UDI-DI Date3 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220517 Date20 Dec 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800039363716 registered 5 Nov 2026 Active
  • FDA 510(k) K220517 decided 20 Dec 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800039363716 listed 3 Jan 2023 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K220079
  2. Cleared FDA 510(k) K220517
  3. Listed FDA GUDID 08800039363716
  4. Registered EUDAMED B-08800039363716

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  • Withdrawn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
Magicore Narrow GUDID
Generic name
Dental implant system
Model / reference
401M3515
Primary DI / UDI-DI
08800039363716
Basic UDI-DI
B-08800039363716
510(k) Number
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Dental implant system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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 system

Cleared under the same submission (K220079)

and 8 more cleared under K220079

Cleared under the same submission (K220517)

and 8 more cleared under K220517

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

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

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

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)