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Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

by Bloomden Bioceramics (HuNan) Co., Ltd 1,000+ variants

Ref 92×75×12 3D-Pro-ML-A4Model HT-plus ST ST-C ST-ML SHT SHT-C SHT-ML UT UT-C UT-ML 3D-pro-ML

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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 Number697456488PDCP00127 Basic UDI-DI 16942075411507UDI-DIDate22 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number16942075411507 UDI-DI Date10 Oct 2024ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank EUDAMED
Bloomden GUDID
Generic Name
Dental appliance fabrication material, ceramic
Model / Reference
HT-plus ST ST-C ST-ML SHT SHT-C SHT-ML UT UT-C UT-ML 3D-pro-ML, 92×75×12 3D-Pro-ML-A4
Primary DI / UDI-DI
16942075411507
Basic UDI-DI
697456488PDCP00127
510(k) Number
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
Germany
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

Manufacturer details

EUDAMED SRN
CN-MF-000019473
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Bloomden Bioceramics (HuNan) Co., Ltd

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Properties

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

Other properties (19)

  • Sterile: 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