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NexxZr® T Multi / Z-95-20-NT-BL20-MT 745549

by Sagemax Bioceramics, Inc.

Ref 745549

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084227112ACERA0143P Basic UDI-DI 00842271176110UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842271176110 UDI-DI Date1 Apr 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
NexxZr T Multi BL2 Z95-20mm EUDAMED
NexxZr® T Multi / Z-95-20-NT-BL20-MT GUDID
Generic Name
Dental appliance fabrication material, ceramic
Device Name
NexxZr Plus, NexxZr Plus Multi, NexxZr Plus Multi 2.0, NexxZr T, NexxZr T Multi
Model / Reference
745549
Primary DI / UDI-DI
00842271176110
Basic UDI-DI
084227112ACERA0143P
FDA Product Code
EIH
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Sagemax Bioceramics, Inc.

See all devices from Sagemax Bioceramics, Inc. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No