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3D Bond

by Augma Biomaterials 3 variants

Ref DD-100-LAM

3D Bond (DD-100-LAM) is a device classified as Class III in the EU and Class II in the US made by Augma Biomaterials, registered in EUDAMED on 5 Feb 2026 (Basic UDI-DI B-07290014838215), cleared under FDA 510(k) K083858 on 17 Mar 2009 and listed in FDA GUDID since 4 Feb 2026 (UDI-DI 07290014838215), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083858

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290014838215 Basic UDI-DI 07290014838215UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290014838215 UDI-DI Date4 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083858 Date17 Mar 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290014838215 registered 5 Feb 2026 Active
  • FDA 510(k) K083858 decided 17 Mar 2009 Active
  • FDA GUDID UDI-DI 07290014838215 listed 4 Feb 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083858
  2. Listed FDA GUDID 07290014838215
  3. Registered EUDAMED B-07290014838215

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  • Withdrawn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

Generic name
Dental bone void filling material, synthetic
Model / reference
DD-100-LAM
Primary DI / UDI-DI
07290014838215
Basic UDI-DI
B-07290014838215
510(k) Number
FDA product code
LYC
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
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
IL-MF-000020802
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under DENTAL GRAFT DEVICES.

Other devices from Augma Biomaterials

  • 3D Bond

    Class III

  • Bond Apatite

    Class III

  • 3D Bond+

    Class III

  • 3D Bond

    Class III

See all devices from Augma Biomaterials →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)