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SuperLine FX4010SWC

by Dentium USA

Ref FX4010SWC

SuperLine FX4010SWC is a device classified as Class IIb in the EU and Class II in the US made by Dentium USA, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI B-D755FX4010SWC0), cleared under FDA 510(k) K160965 on 13 Jan 2017 and listed in FDA GUDID since 29 Oct 2015 (UDI-DI D755FX4010SWC0), 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) K160965

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-D755FX4010SWC0 Basic UDI-DI D755FX4010SWC0UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK160965 Date13 Jan 2017DecidedStatusActive
United StatesGUDID listing GUDID NumberD755FX4010SWC0 UDI-DI Date29 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-D755FX4010SWC0 registered 17 Sep 2026 Active
  • FDA 510(k) K160965 decided 13 Jan 2017 Active
  • FDA GUDID UDI-DI D755FX4010SWC0 listed 29 Oct 2015 Listed

Timeline

3 dated events

  1. Listed FDA GUDID D755FX4010SWC0
  2. Cleared FDA 510(k) K160965
  3. Registered EUDAMED B-D755FX4010SWC0

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  • Withdrawn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
SuperLine® EUDAMED
SuperLine GUDID
Generic name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
FX4010SWC
Primary DI / UDI-DI
D755FX4010SWC0
Basic UDI-DI
B-D755FX4010SWC0
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 — 10 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 (K160965)

and 8 more cleared under K160965

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)