Dental Burs
Ref TIA-FO-25BModel 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
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
Dental burs are used in dentistry to shape and smooth out tooth surfaces, promoting healthy gums and oral hygiene. These versatile instruments come in various types, each designed for specific applications, and can be sterilized and reused to minimize contamination risks.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081019026DBKL 00810190269626 | Date4 Nov 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- 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-FO-25B
- Primary DI / UDI-DI
- 00810190269626
- 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
Other devices from TiaDent Inc
Properties
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