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DentaSonic Professional Kit 2

by DS Dentasonic SA EUDAMED

Active European Union

Ref DSPK2-1Y, DSPK2-6-1Y, Cat.7.2.2025 EN low, Cat. 7.2.2025 EN lowModel 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  • Withdrawn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

Trade Name
DentaSonic Professional Kit 2
Dentasonic
Device Name
Interproximal Reduction Strips
Model / Reference
DSPK2-2Y, DSPK2-1Y, DSPK2-6-1Y, Cat.7.2.2025 EN low, Cat. 7.2.2025 EN low
Primary DI / UDI-DI
07640269141880, 07640269142467, 07640269141958, 07640269140081
Basic UDI-DI
764026914K21200TK, 764026914S21100WN
EMDN Code
Q01010403 Dental abrasive and polishing materials
Device Class
Class IIa
Class I
Market of Registration
Italy
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

From the manufacturer

Manufacturer's product page: Professional Kit 2

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See all devices from DS Dentasonic SA →

Properties

Show 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