Unbreakable by TCS

by Thermoplastic Comfort Systems, Inc. 72 variants

Ref 4000-01/MF1Model TCS Dental Resins

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	Number++D805TCSRESINSS8 Basic UDI-DI +D805400001MF12UDI-DI	Date27 May 2026Registered	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Withdrawn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

Map note: Northern Ireland has no dot of its own.

Specification

EUDAMED

Device Name: TCS Dental Resins
Model / Reference: TCS Dental Resins, 4000-01/MF1

Primary DI / UDI-DI: +D805400001MF12
Basic UDI-DI: ++D805TCSRESINSS8
EMDN Code: Q010699 Materials for the preparation of custom-made dental devices - other

Device Class: Class I
EU market of registration: Romania

Manufacturer details

EUDAMED SRN: US-MF-000025565
Authorised representative: MDSS GmbH DE-AR-000005430

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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