Dental Impression Material

by Chemoment Materials Co., ltd 3 variants

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

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221668↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number697600958DIM01HM Basic UDI-DI 06976009580048UDI-DI	Date12 Jul 2023Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK221668	Date8 Aug 2022Issued	StatusActive

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 23 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k) Active
European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name: Dental Impression Material
Model / Reference: Type 0, type 1, type 2 and type 3, type 3

Primary DI / UDI-DI: 06976009580048
Basic UDI-DI: 697600958DIM01HM
EMDN Code: Q01020199 Dental impression materials - other

Device Class: Class I
EU market of registration: Germany

Manufacturer details

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

Other devices from Chemoment Materials Co., ltd

Properties

Other properties (13)

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