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Biotem AAITB35425

by Biotem Co., ltd

Ref AAITB35425

Biotem AAITB35425 is a device classified as Class IIb in the EU and Class II in the US made by Biotem Co., ltd, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI B-08800036212895), cleared under FDA 510(k) K171185 on 1 Dec 2017 and listed in FDA GUDID since 1 Jun 2018 (UDI-DI 08800036212895), 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) K171185

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-08800036212895 Basic UDI-DI 08800036212895UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800036212895 UDI-DI Date1 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171185 Date1 Dec 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800036212895 registered 25 Jun 2026 Active
  • FDA 510(k) K171185 decided 1 Dec 2017 Active
  • FDA GUDID UDI-DI 08800036212895 listed 1 Jun 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171185
  2. Listed FDA GUDID 08800036212895
  3. Registered EUDAMED B-08800036212895

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  • Withdrawn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
Biotem
Generic name
Dental implant system
Model / reference
AAITB35425
Primary DI / UDI-DI
08800036212895
Basic UDI-DI
B-08800036212895
510(k) Number
FDA product code
NHA
EMDN code
P01020101 Dental implants
GMDN term
Dental implant system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

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 (K171185)

and 8 more cleared under K171185

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Biotem Co., ltd

See all devices from Biotem Co., ltd →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)