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Dental Impression Material

by Chemoment Materials Co., ltd

Ref TYPE 0Model Type 0, type 1, type 2 and type 3

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, self-declared

Class I: no certifier involved

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 Number697600958DIM01HM Basic UDI-DI 06976009580017UDI-DIDate12 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06976009580017 UDI-DI Date18 Jan 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Chemoment
Generic Name
Silicone dental impression material
Device Name
Dental Impression Material
Model / Reference
Type 0, type 1, type 2 and type 3
Primary DI / UDI-DI
06976009580017
Basic UDI-DI
697600958DIM01HM
510(k) Number
FDA Product Code
ELW
EMDN Code
Q01020199 Dental impression materials - other
GMDN Term
Silicone dental impression material
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3660
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000035833
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Silicone dental impression material

Other devices from Chemoment Materials Co., ltd

Properties

  • Single Use
  • Expiration Date
  • Manufacturing Date

Other properties (21)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No