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PMMA BLOCK Shade: A2 - PMMA BLOCK Shade: A2

by Huliang(Shanghai) Biotech Co., Ltd.

Ref Shade: A2; Spec:98*10mm; Net Weight:87gModel Single Layer; Multi-Layer

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 Number6975187612aSZKQG Basic UDI-DI 06975187610035UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06975187610035 UDI-DI Date28 Dec 2023ListedStatusListed 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  • Withdrawn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
Pmma Block
Generic Name
Temporary dental crown/bridge
Model / Reference
Shade: A2, Spec:98*10mm, Net Weight:87g, Single Layer, Multi-Layer
Primary DI / UDI-DI
06975187610035
Basic UDI-DI
6975187612aSZKQG
510(k) Number
FDA Product Code
EBI, MQC, EBG
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Temporary dental crown/bridge
Models / Variants
PMMA BLOCK Shade: A2
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3760, 872.3770
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K223706)

Show all (12)

Other devices from Huliang(Shanghai) Biotech Co., Ltd.

See all devices from Huliang(Shanghai) Biotech Co., Ltd. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No