Dental Temporary Polymer-based Crown and Bridge Materials

by Qinhuangdao Primus Biotech Limited

Ref Transparent colorModel Transparent color, Gum color, Cocoa color, Ivory white, Phantom Gray or customized

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697734798QHDBRS001A8 Basic UDI-DI 06977347980309UDI-DI	Date15 Nov 2024Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Dental Temporary Polymer-based Crown and Bridge Materials
Model / Reference: Transparent color, Gum color, Cocoa color, Ivory white, Phantom Gray or customized

Primary DI / UDI-DI: 06977347980309
Basic UDI-DI: 697734798QHDBRS001A8
EMDN Code: Q01020199 Dental impression materials - other

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000041316
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Qinhuangdao Primus Biotech Limited

Brisk

Class I

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