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OSSIX™ Bone 0.125 cc

by Datum Dental Ltd

Ref 32310009

OSSIX™ Bone 0.125 cc (OXB0125) 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-07290015477215), cleared under FDA 510(k) K163714 on 18 Jul 2017 and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 07290015477215), 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) K163714

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-07290015477215 Basic UDI-DI 07290015477215UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290015477215 UDI-DI Date31 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163714 Date18 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290015477215 registered 4 Nov 2026 Active
  • FDA 510(k) K163714 decided 18 Jul 2017 Active
  • FDA GUDID UDI-DI 07290015477215 listed 31 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163714
  2. Listed FDA GUDID 07290015477215
  3. Registered EUDAMED B-07290015477215

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  • Withdrawn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™ Bone GUDID
Generic name
Dental bone void filling material, synthetic
Device name
OSSIX® Bone 5*5*5 (0.125 cc)
Model / Ref / Catalog
32310009 EUDAMED
0.125 cc GUDID
OXB0125 GUDID
Primary DI / UDI-DI
07290015477215
Basic UDI-DI
B-07290015477215
510(k) Number
FDA product code
NPM
EMDN code
Q010302 Dental graft devices
GMDN term
Dental bone void filling material, synthetic
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
Size
Depth — 5 Millimeter
Length — 5 Millimeter
Height — 5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
32310009
GUDID
0.125 cc
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: Dental bone matrix implant, synthetic

Cleared under the same submission (K163714)

Similar devices in this category

Other devices filed under DENTAL GRAFT DEVICES.

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
Other properties (18, all answered No)