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Dental Bur

by Swordental Co., Ltd China EUDAMED

Ref SD-10 Cone, M Pear, RA01, T Depth Gauge, B Narrow Neck Round, O Biconical, C Inverted Cone, SD-15 Smooth Round-Top Cone, SD-8 Cross-Cut Flat-End Cone, HP05, RA03, SD-2 Inverted Cone, Q Torpedo, HP04, HP30, SD-4 Flat-End Cone, SD-14 Cross-Cut Pear, RA10, HP41, HP42, A Round, HP03, SD-7 Cross-Cut Cylinder, D Wheel, RA05, Z-6 Curved, F Flat-End Cone, Z-7 Torch-shaped, HP02

EMDN Q010501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697867861WDB3S Basic UDI-DIDate5 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dental Bur
Model / Reference
SD-10 Cone, M Pear, RA01, T Depth Gauge, B Narrow Neck Round, O Biconical, C Inverted Cone, SD-15 Smooth Round-Top Cone, SD-8 Cross-Cut Flat-End Cone, HP05, RA03, SD-2 Inverted Cone, Q Torpedo, HP04, HP30, SD-4 Flat-End Cone, SD-14 Cross-Cut Pear, RA10, HP41, HP42, A Round, HP03, SD-7 Cross-Cut Cylinder, D Wheel, RA05, Z-6 Curved, F Flat-End Cone, Z-7 Torch-shaped, HP02
Primary DI / UDI-DI
06978678610101, 06978678610293, 06978678610378, 06978678610354, 06978678610200, 06978678610330, 06978678610217, 06978678610156, 06978678610088, 06978678610491, 06978678610392, 06978678610026, 06978678610347, 06978678610484, 06978678610514, 06978678610040, 06978678610149, 06978678610439, 06978678610545, 06978678610552, 06978678610194, 06978678610477, 06978678610071, 06978678610231, 06978678610415, 06978678610613, 06978678610255, 06978678610620, 06978678610460
Basic UDI-DI
697867861WDB3S
EMDN Code
Q010501 Dental burs and abrasive disks, single-use
Device Class
Class I
Market of Registration
Austria
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000051060
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

Related devices

Category: Carbide dental bur, single-use

Other devices from Swordental Co., Ltd

See all devices from Swordental Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reprocessed NoEUDAMEDYesEUDAMED
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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

Sources (29)

  • EUDAMED 29d72bd8-e068-486c-818c-a95f7c9a8e28 61 fields · synced 22 Oct 2026
  • EUDAMED 06978678610293|697867861WDB3S 61 fields · synced 11 May 2026
  • EUDAMED 06978678610378|697867861WDB3S 61 fields · synced 16 May 2026
  • EUDAMED 06978678610354|697867861WDB3S 61 fields · synced 16 May 2026
  • EUDAMED 06978678610200|697867861WDB3S 61 fields · synced 16 May 2026
  • EUDAMED 06978678610330|697867861WDB3S 61 fields · synced 17 May 2026
  • EUDAMED 06978678610217|697867861WDB3S 61 fields · synced 17 May 2026
  • EUDAMED 06978678610156|697867861WDB3S 61 fields · synced 17 May 2026
  • EUDAMED 06978678610088|697867861WDB3S 61 fields · synced 17 May 2026
  • EUDAMED 06978678610491|697867861WDB3S 61 fields · synced 17 May 2026
  • EUDAMED 06978678610392|697867861WDB3S 61 fields · synced 17 May 2026
  • EUDAMED 06978678610026|697867861WDB3S 61 fields · synced 17 May 2026
  • EUDAMED 06978678610347|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610484|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610514|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610040|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610149|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610439|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610545|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610552|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610194|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610477|697867861WDB3S 61 fields · synced 18 May 2026
  • EUDAMED 06978678610071|697867861WDB3S 61 fields · synced 19 May 2026
  • EUDAMED 06978678610231|697867861WDB3S 61 fields · synced 19 May 2026
  • EUDAMED 06978678610415|697867861WDB3S 61 fields · synced 19 May 2026
  • EUDAMED 06978678610613|697867861WDB3S 61 fields · synced 19 May 2026
  • EUDAMED 06978678610255|697867861WDB3S 61 fields · synced 19 May 2026
  • EUDAMED 06978678610620|697867861WDB3S 61 fields · synced 19 May 2026
  • EUDAMED 06978678610460|697867861WDB3S 61 fields · synced 19 May 2026