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Zcore ZL100

by Osteogenics Biomedical, Inc.

Ref ZL100

Zcore ZL100 is a device classified as Class III in the EU and Class II in the US made by Osteogenics Biomedical, Inc., registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI B-D765ZL1000) and listed in FDA GUDID since 29 Apr 2016 (UDI-DI D765ZL1000), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-D765ZL1000 Basic UDI-DI D765ZL1000UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD765ZL1000 UDI-DI Date29 Apr 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-D765ZL1000 registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI D765ZL1000 listed 29 Apr 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D765ZL1000
  2. Registered EUDAMED B-D765ZL1000

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ZCORE™ Porcine Xenograft Particulate EUDAMED
Zcore GUDID
Generic name
Dental bone void filling material, animal-derived
Device name
Porcine Anorganic Bone Mineral in Jar or Syringe
Model / reference
ZL100
Primary DI / UDI-DI
D765ZL1000
Basic UDI-DI
B-D765ZL1000
FDA product code
NPM
EMDN code
Q010302 Dental graft devices
GMDN term
Dental bone void filling material, animal-derived
Device class
Class III EUDAMED
Class II GUDID
Regulation number
872.3930
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1.0 Centiliter

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.

Related devices

Category: Dental bone matrix implant, animal-derived

Similar devices in this category

Other devices filed under DENTAL GRAFT DEVICES.

Other devices from Osteogenics Biomedical, Inc.

See all devices from Osteogenics Biomedical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)