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Dentasonic EVO-Set

by DS Dentasonic SA EUDAMED

Active European Union

Ref EVO-SetModel DSPK2-2Y

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764026914K21200TK Basic UDI-DIDate10 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
DentaSonic Professional Kit 2
Model / Reference
DSPK2-2Y, EVO-Set
Primary DI / UDI-DI
07640269142443
Basic UDI-DI
764026914K21200TK
EMDN Code
Q01010403 Dental abrasive and polishing materials
Device Class
Class IIa
Medical Purpose
The ultimative Professional Kit in a cardboard box with a complete range of DiaStrip for the bilateral and monolateral controlled non-invasive IPR of the tooth size and the proximal finishing & polishing in orthodontics, aligners, and/or restorative. Water cooled oscillating handpiece with a 4:1 ratio, in addition also a 2nd. oscillating head, and one measuring gauge with 6 thicknesses.

Manufacturer details

EUDAMED SRN
CH-PR-000047343

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Properties

Show properties
Other properties (1)
  • Sterile: No