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Ossix® Plus OXP3040

by Datum Dental Ltd

Ref 32905286

Ossix® Plus OXP3040 is a device classified as Class III in the EU and Class II in the US made by Datum Dental Ltd, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-07290015477710), cleared under FDA 510(k) K160281 on 4 Aug 2016 and listed in FDA GUDID since 27 Sep 2015 (UDI-DI 07290015477710), active as of 9 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 9 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160281

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290015477710 Basic UDI-DI 07290015477710UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160281 Date4 Aug 2016DecidedStatusActive
United StatesGUDID listing GUDID Number07290015477710 UDI-DI Date27 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290015477710 registered 4 Nov 2026 Active
  • FDA 510(k) K160281 decided 4 Aug 2016 Active
  • FDA GUDID UDI-DI 07290015477710 listed 27 Sep 2015 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 07290015477710
  2. Cleared FDA 510(k) K160281
  3. Registered EUDAMED B-07290015477710

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  • Withdrawn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
Ossix EUDAMED
Ossix® Plus GUDID
Generic name
Collagen dental regeneration membrane
Device name
Ossix® Plus 30*40
Model / reference
32905286 EUDAMED
OXP3040 GUDID
Primary DI / UDI-DI
07290015477710
Basic UDI-DI
B-07290015477710
FDA product code
NPL
EMDN code
Q010301 Periodontal membranes
GMDN term
Collagen dental regeneration membrane
Device class
Class III EUDAMED
Class II GUDID
Regulation number
872.3930
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 40 Millimeter
Width — 30 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
32905286
GUDID
OXP3040
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Collagen dental regeneration membrane

Cleared under the same submission (K160281)

Similar devices in this category

Other devices filed under PERIODONTAL MEMBRANES.

Other devices from Datum Dental Ltd

See all devices from Datum Dental Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)