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Biotem HAI48604

by Biotem Co., ltd

Ref HAI48604

Biotem HAI48604 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 28 May 2026 (Basic UDI-DI B-08800036203947), cleared under FDA 510(k) K171185 on 1 Dec 2017 and listed in FDA GUDID since 1 Jun 2018 (UDI-DI 08800036203947), active as of 23 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 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800036203947 Basic UDI-DI 08800036203947UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800036203947 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-08800036203947 registered 28 May 2026 Active
  • FDA 510(k) K171185 decided 1 Dec 2017 Active
  • FDA GUDID UDI-DI 08800036203947 listed 1 Jun 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171185
  2. Listed FDA GUDID 08800036203947
  3. Registered EUDAMED B-08800036203947

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  • Withdrawn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
HAI48604
Description
Biotem IR HEALING ABUTMENT 5.5mm(D)X4.0mm(H)
Primary DI / UDI-DI
08800036203947
Basic UDI-DI
B-08800036203947
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

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 08800036203947: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 08800036203947: EUDAMED states Yes, FDA GUDID states No.

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

  • Supplied sterile NoEUDAMEDYesGUDID
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)