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510(k) K033675

PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER by Sirona Dental Systems GmbH — Product Code KOJ

K033675 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER". The FDA issued a decision of Substantially Equivalent on January 15, 2004. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Sirona Dental Systems GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2004
Date Received
November 24, 2003
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 Sirona Dental Systems GmbH

  • K160099 — CEREC SpeedGlaze (June 2, 2016)
  • K151045 — TENEO Dental Treatment Unit and Accessories (July 24, 2015)
  • K150909 — INTEGO Family and Accesories (July 17, 2015)
  • K150750 — Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (July 2, 2015)
  • K150217 — ORTHOPHOS SL (May 8, 2015)
  • K131319 — T1/T2/T3 TURBINE FAMILY (May 30, 2014)
  • K132773 — SIDEXIS 4 (December 11, 2013)
  • K123664 — INCORIS ZI (April 8, 2013)
  • K123952 — CEREC BLOCS C IN (March 20, 2013)
  • K123070 — GALILEOS FAMILY (March 15, 2013)

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)
  • 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)
  • K014249 — JETPOLISHER (February 19, 2002)

FDA data resources