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IU Fixture FIU55100

by WARANTEC.Co., Ltd

Ref FIU55100

IU Fixture FIU55100 is a device classified as Class IIb in the EU and Class II in the US made by WARANTEC.Co., Ltd, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-08800026101031), cleared under FDA 510(k) K172345 on 18 Jun 2018 and listed in FDA GUDID since 12 Apr 2023 (UDI-DI 08800026101031), 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) K172345

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-08800026101031 Basic UDI-DI 08800026101031UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800026101031 UDI-DI Date12 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172345 Date18 Jun 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800026101031 registered 4 Nov 2026 Active
  • FDA 510(k) K172345 decided 18 Jun 2018 Active
  • FDA GUDID UDI-DI 08800026101031 listed 12 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172345
  2. Listed FDA GUDID 08800026101031
  3. Registered EUDAMED B-08800026101031

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  • Withdrawn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
IU Fixture
Generic name
Dental implant system
Device name
IU Implant Fixture
Model / reference
FIU55100
Primary DI / UDI-DI
08800026101031
Basic UDI-DI
B-08800026101031
510(k) Number
FDA product code
DZE, NHA
EMDN code
P01020101 Dental implants
GMDN term
Dental implant system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640, 872.3630
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
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 (K172345)

and 8 more cleared under K172345

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from WARANTEC.Co., Ltd

See all devices from WARANTEC.Co., Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)