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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 Jan 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 41 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 15, 2004
Date Received
Nov 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
510(k)

Other clearances by Sirona Dental Systems GmbH

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

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • K063236 — BETA-POWDER (Feb 16, 2007)
  • K042872 — RONDOFLEX PLUS 360 (Nov 23, 2004)
  • K033215 — PREPAIR (Jan 9, 2004)
  • K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT (Oct 9, 2003)
  • K030292 — GROMAN PREPMASTER (Apr 15, 2003)
  • K021450 — CLINPRO PROPHY POWDER (Aug 1, 2002)
  • K014188 — NEW PROPHY POWDER (Mar 15, 2002)
  • K014252 — JETSTREAM (Feb 19, 2002)
  • K014249 — JETPOLISHER (Feb 19, 2002)

FDA data resources

Source: FDA 510(k) database entry for K033675. Report a data issue: hello@regdatalab.com.