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Torque control device for ratchet 055110

by BIO CONCEPT Co., Ltd.

Ref 069476003001001E3

Torque control device for ratchet 055110 is a device classified as Class I in the EU and Class II in the US made by BIO CONCEPT Co., Ltd., registered in EUDAMED on 9 May 2026 (Basic UDI-DI 069476003001001E3), cleared under FDA 510(k) K150388 on 12 Nov 2015 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06947600301981), active as of 22 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 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number069476003001001E3 Basic UDI-DI 06947600301981UDI-DIDate9 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06947600301981 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 069476003001001E3 registered 9 May 2026 Active
  • FDA 510(k) K150388 decided 12 Nov 2015 Active
  • FDA GUDID UDI-DI 06947600301981 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150388
  2. Listed FDA GUDID 06947600301981
  3. Registered EUDAMED 069476003001001E3

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  • Withdrawn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
Dental Implantation Instruments EUDAMED
Torque control device for ratchet GUDID
Generic name
Dental implant system
Model / reference
069476003001001E3 EUDAMED
055110 GUDID
Primary DI / UDI-DI
06947600301981
Basic UDI-DI
069476003001001E3
510(k) Number
FDA product code
DZE
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Dental implant system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
069476003001001E3
GUDID
055110
Device classEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Device class is stated on each registry's own scale: Class I 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 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from BIO CONCEPT Co., Ltd.

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

Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)