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Implant, Regular 316060G

by BIO CONCEPT Co., Ltd.

Ref 316060G

Implant, Regular 316060G 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 29 Oct 2026 (Basic UDI-DI B-06947600317999), cleared under FDA 510(k) K192274 on 18 Jun 2020 and listed in FDA GUDID since 21 Nov 2024 (UDI-DI 06947600317999), 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) K192274

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-06947600317999 Basic UDI-DI 06947600317999UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06947600317999 UDI-DI Date21 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192274 Date18 Jun 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06947600317999 registered 29 Oct 2026 Active
  • FDA 510(k) K192274 decided 18 Jun 2020 Active
  • FDA GUDID UDI-DI 06947600317999 listed 21 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192274
  2. Listed FDA GUDID 06947600317999
  3. Registered EUDAMED B-06947600317999

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  • Withdrawn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
Implant，Regular EUDAMED
Implant, Regular GUDID
Generic name
Dental implant system
Device name
Dental Implants
Model / reference
316060G
Primary DI / UDI-DI
06947600317999
Basic UDI-DI
B-06947600317999
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 (K192274)

and 8 more cleared under K192274

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
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)