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Denture Base Polymers Type 2 class 1

by Shandong Huge Dental Material Corporation

Ref Type 2 class 1 Self Curing/Powder 1000gModel Type 1 class 1(A) Traditional Heat Curing, Type 1 class 1(B) Fast Heat Curing, Type 2 class 1 Self Curing

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6909412YCJT1013M Basic UDI-DI 06970402678036UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06970402678036 UDI-DI Date26 Oct 2025ListedStatusListed 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 25 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  • Withdrawn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
Denture Base Polymers
Generic Name
Dental appliance fabrication material, resin
Model / Ref / Catalog
Type 1 class 1(A) Traditional Heat Curing EUDAMED
Type 1 class 1(B) Fast Heat Curing EUDAMED
Type 2 class 1 Self Curing EUDAMED
Type 2 class 1 Self Curing/Powder 1000g EUDAMED
Type 2 class 1 GUDID
(powder) 1kg GUDID
Primary DI / UDI-DI
06970402678036
Basic UDI-DI
6909412YCJT1013M
510(k) Number
FDA Product Code
EBI
EMDN Code
Q0102050199 Dentistry resins - other
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3760
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No
  • Manufacturing Date: No