Dental Diamond Bur

Ref ROUNDModel ROUND;INVERTED CONE;DIABL;BARREL;POINTED BUR;WHEEL;FLAT END TAPER;BEVELED CYLINDER;ROUND END CYLINDER;POINTED CONE;FLAT END CYLINDER;SHOULDER SPECIAL;ROUND END TAPER;PEAR SPECIAL;LASER MARKER;GUIDE PIN;DEPTH MARKER;BUD;INTERDENTAL;

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	Number697894960DIAMONDBUR47 Basic UDI-DI 06978949600008UDI-DI	Date29 Sep 2025Registered	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Withdrawn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 Diamond Bur
Model / Reference: ROUND, INVERTED CONE, DIABL, BARREL, POINTED BUR, WHEEL, FLAT END TAPER, BEVELED CYLINDER, ROUND END CYLINDER, POINTED CONE, FLAT END CYLINDER, SHOULDER SPECIAL, ROUND END TAPER, PEAR SPECIAL, LASER MARKER, GUIDE PIN, DEPTH MARKER, BUD, INTERDENTAL

Primary DI / UDI-DI: 06978949600008
Basic UDI-DI: 697894960DIAMONDBUR47
EMDN Code: Q010501 Dental burs and abrasive disks, single-use

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000049666
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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