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Implantium FX3808MLC

by Dentium USA

Ref FX3808MLC

Implantium FX3808MLC is a device classified as Class IIb in the EU and Class II in the US made by Dentium USA, registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI B-D755FX3808MLC0), cleared under FDA 510(k) K041368 on 29 Jul 2004 and listed in FDA GUDID since 29 Oct 2015 (UDI-DI D755FX3808MLC0), active as of 7 Nov 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K041368

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-D755FX3808MLC0 Basic UDI-DI D755FX3808MLC0UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD755FX3808MLC0 UDI-DI Date29 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK041368 Date29 Jul 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-D755FX3808MLC0 registered 21 Sep 2026 Active
  • FDA 510(k) K041368 decided 29 Jul 2004 Active
  • FDA GUDID UDI-DI D755FX3808MLC0 listed 29 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1119-2007 FDA Unclassified (pre-2012) initiated 29 Jun 2007

    Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distributed to date.

Timeline

4 dated events

  1. Cleared FDA 510(k) K041368
  2. Recall initiated FDA recalls Z-1119-2007
  3. Listed FDA GUDID D755FX3808MLC0
  4. Registered EUDAMED B-D755FX3808MLC0

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  • Withdrawn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
Implantium® EUDAMED
Implantium GUDID
Generic name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
FX3808MLC
Primary DI / UDI-DI
D755FX3808MLC0
Basic UDI-DI
B-D755FX3808MLC0
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
Türkiye
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 8 Millimeter
Outer Diameter — 4 Millimeter

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 (K041368)

and 8 more cleared under K041368

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Dentium USA

See all devices from Dentium USA →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)