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A-Silicone for Bite Registration Dispenser-mix Normal Set

by Shandong Huge Dental Material Corporation

Ref Dispenser-Mix Normal Set/50ml*2Model Dispenser-Mix Normal Set, Dispenser-Mix Fast Set

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6909412YHJL1013W Basic UDI-DI 06970402679873UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06970402679873 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 24 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  • Withdrawn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
A-Silicone for Bite Registration
Generic Name
Silicone dental impression material
Model / Ref / Catalog
Dispenser-Mix Normal Set, Dispenser-Mix Fast Set, Dispenser-Mix Normal Set/50ml*2, 50ml/bio-cartridge, 2 bio-cartridges/box
Primary DI / UDI-DI
06970402679873
Basic UDI-DI
6909412YHJL1013W
510(k) Number
FDA Product Code
ELW
EMDN Code
Q01020104 Dental impression silicones
GMDN Term
Silicone dental impression material
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Dispenser-Mix Normal Set, Dispenser-Mix Fast Set
Dispenser-Mix Normal Set/50ml*2
GUDID
Dispenser-mix Normal Set
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K201684)

Other devices from Shandong Huge Dental Material Corporation

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • 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
  • Manufacturing Date: No