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Dental Filling/Restorative Polymer Based Block

by Liaoning Upcera Co Ltd 346 variants

Ref /Model Hyramic CAD/CAM Restorative

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number694138229983J7 Basic UDI-DI 06941382250802UDI-DIDate23 Mar 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06941382250802 UDI-DI Date16 Mar 2019ListedStatusListed 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  • Withdrawn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
Tooth Shade Resin Material
Generic Name
Dentine bonding agent/set
Device Name
Dental Filling/Restorative Polymer Based Block
Model / Reference
Hyramic CAD/CAM Restorative EUDAMED
/ EUDAMED
HT-M-B3-R(18-14-12) GUDID
Primary DI / UDI-DI
06941382250802
Basic UDI-DI
694138229983J7
Direct Marketing DI
06941382250802
FDA Product Code
EBF
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dentine bonding agent/set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3690
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Hyramic CAD/CAM Restorative
/
GUDID
HT-M-B3-R(18-14-12)
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000013088
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Liaoning Upcera Co., Ltd.

See all devices from Liaoning Upcera Co., Ltd. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No