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I-FIX Angled Type Fixture DMAF2016L

by Dentis Co., Ltd

Ref DMAF2016L

I-FIX Angled Type Fixture DMAF2016L is a device classified as Class IIb in the EU and Class II in the US made by Dentis Co., Ltd, registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI B-08806169104434), cleared under FDA 510(k) K083586 on 29 Apr 2009 and listed in FDA GUDID since 31 Jul 2015 (UDI-DI 08806169104434), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083586

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806169104434 Basic UDI-DI 08806169104434UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806169104434 UDI-DI Date31 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083586 Date29 Apr 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08806169104434 registered 8 Oct 2026 Active
  • FDA 510(k) K083586 decided 29 Apr 2009 Active
  • FDA GUDID UDI-DI 08806169104434 listed 31 Jul 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083586
  2. Listed FDA GUDID 08806169104434
  3. Registered EUDAMED B-08806169104434

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  • Withdrawn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
I-FIX Angled Type Fixture
Generic name
Screw endosteal dental implant, two-piece
Model / reference
DMAF2016L
Primary DI / UDI-DI
08806169104434
Basic UDI-DI
B-08806169104434
510(k) Number
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, two-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
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: Screw endosteal dental implant, two-piece

Cleared under the same submission (K083586)

and 8 more cleared under K083586

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Dentis Co., Ltd

See all devices from Dentis Co., Ltd →

Properties

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