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510(k) K010816

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

K010816 is an FDA 510(k) premarket notification submitted by Ronvig A/S for the device "DENTO-PREP PARTICLE MICROBLASTER". The FDA issued a decision of Substantially Equivalent on May 10, 2001. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Ronvig A/S has at least 1 other 510(k) clearance on record.

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)

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • K063236 — BETA-POWDER (February 16, 2007)
  • K042872 — RONDOFLEX PLUS 360 (November 23, 2004)
  • K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (January 15, 2004)
  • 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)
  • K014252 — JETSTREAM (February 19, 2002)

FDA data resources