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Unbreakable by TCS

by Thermoplastic Comfort Systems, Inc. 72 variants

Ref 4000-01/M2Model 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D805TCSRESINSS8 Basic UDI-DI +D805400001M22UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
TCS Dental Resins
Model / Reference
TCS Dental Resins, 4000-01/M2
Primary DI / UDI-DI
+D805400001M22
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

Other devices from Thermoplastic Comfort Systems, Inc.

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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