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Kontact S K3612S

by Biotech Dental

Ref K3612SModel IMPLANT

Kontact S K3612S is a device classified as Class IIb in the EU and Class II in the US made by Biotech Dental, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-03701045271222), cleared under FDA 510(k) K213997 on 15 Jul 2022 and listed in FDA GUDID since 26 Jul 2022 (UDI-DI 03701045271222), 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) K213997

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-03701045271222 Basic UDI-DI 03701045271222UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701045271222 UDI-DI Date26 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213997 Date15 Jul 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03701045271222 registered 30 Oct 2026 Active
  • FDA 510(k) K213997 decided 15 Jul 2022 Active
  • FDA GUDID UDI-DI 03701045271222 listed 26 Jul 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213997
  2. Listed FDA GUDID 03701045271222
  3. Registered EUDAMED B-03701045271222

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  • Withdrawn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
Kontact S
Generic name
Dental implant system
Model / reference
K3612S, IMPLANT
Primary DI / UDI-DI
03701045271222
Basic UDI-DI
B-03701045271222
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 Conditional

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 (K213997)

and 8 more cleared under K213997

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Biotech Dental

See all devices from Biotech Dental →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)