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Bone Level Implant 112010

by BIO CONCEPT Co., Ltd.

Ref 112010

Bone Level Implant 112010 is a device classified as Class IIb in the EU and Class II in the US made by BIO CONCEPT Co., Ltd., registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-06947600305095), cleared under FDA 510(k) K150388 on 12 Nov 2015 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06947600305095), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150388

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06947600305095 Basic UDI-DI 06947600305095UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06947600305095 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150388 Date12 Nov 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06947600305095 registered 12 Oct 2026 Active
  • FDA 510(k) K150388 decided 12 Nov 2015 Active
  • FDA GUDID UDI-DI 06947600305095 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150388
  2. Listed FDA GUDID 06947600305095
  3. Registered EUDAMED B-06947600305095

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  • Withdrawn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
Dental Implants EUDAMED
Bone Level Implant GUDID
Generic name
Dental implant system
Model / reference
112010
Primary DI / UDI-DI
06947600305095
Basic UDI-DI
B-06947600305095
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
Germany
GUDID distribution status
In Commercial Distribution

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 (K150388)

and 8 more cleared under K150388

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from BIO CONCEPT Co., Ltd.

See all devices from BIO CONCEPT Co., Ltd. →

Properties

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