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Dental Burs

by TiaDent Inc 954 variants

Ref TIA-SF-21Model TIA-TR-26EF TIA-TR-25EF TIA-TR-21EF TIA-TR-14EF TIA-TR-13EF TIA-TR-12EF TIA-TR-11EF TIA-TF-21EF TIA-TF-12EF TIA-TC-32EF TIA-TC-31EF TIA-TC-30EF TIA-TC-26EF TIA-TC-21EF TIA-TC-20EF TIA-TC-19EF TIA-TC-17EF TIA-TC-14EF TIA-TC-12EF TIA-TC-11EF

Active European Union

CE MDR

Valid until

No date given

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 25 Oct 2026. What this means

Overview

A comprehensive guide to the Dental Burs medical device, featuring its key features, regulatory compliance, and FAQs.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081019026DBKL Basic UDI-DI 00810190267905UDI-DIDate4 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Model / reference
TIA-TR-26EF TIA-TR-25EF TIA-TR-21EF TIA-TR-14EF TIA-TR-13EF TIA-TR-12EF TIA-TR-11EF TIA-TF-21EF TIA-TF-12EF TIA-TC-32EF TIA-TC-31EF TIA-TC-30EF TIA-TC-26EF TIA-TC-21EF TIA-TC-20EF TIA-TC-19EF TIA-TC-17EF TIA-TC-14EF TIA-TC-12EF TIA-TC-11EF, TIA-SF-21
Primary DI / UDI-DI
00810190267905
Basic UDI-DI
081019026DBKL
EMDN code
Q010501 Dental burs and abrasive disks, single-use
Device class
Class I
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000049704
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Sterilise before use

Other properties (13)

  • Supplied sterile: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No