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510(k) K010816

DENTO-PREP PARTICLE MICROBLASTER by Ronvig A/S — Product Code KOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2001
Date Received
March 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airbrush
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
Submission Type

Other clearances by Ronvig A/S

  • K032925 — B&R DEVICE (December 22, 2003)

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  • K033215 — PREPAIR (January 9, 2004)
  • K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT (October 9, 2003)
  • K030292 — GROMAN PREPMASTER (April 15, 2003)
  • K021450 — CLINPRO PROPHY POWDER (August 1, 2002)
  • K014188 — NEW PROPHY POWDER (March 15, 2002)
  • K014249 — JETPOLISHER (February 19, 2002)