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510(k) K021450

CLINPRO PROPHY POWDER by 3M Espe AG Dental Products — Product Code KOJ

K021450 is an FDA 510(k) premarket notification submitted by 3M Espe AG Dental Products for the device "CLINPRO PROPHY POWDER". The FDA issued a decision of Substantially Equivalent on August 1, 2002. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. 3M Espe AG Dental Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2002
Date Received
May 6, 2002
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 3M Espe AG Dental Products

  • K100908 — UNICEM HM (June 22, 2010)
  • K100756 — MALTA (June 2, 2010)
  • K094007 — UNICEM (April 8, 2010)
  • K093721 — COSP2 (February 19, 2010)
  • K091826 — ELEGANT (September 25, 2009)
  • K090718 — BELLUS SHADING KIT (September 21, 2009)
  • K080514 — PECD-01 AND PECD QUICK-01 (March 26, 2008)
  • K072055 — LAVA FRAME, LAVA FRAME SHADE (February 26, 2008)
  • K073296 — TEMPXN28 (January 9, 2008)
  • K071131 — UNO (July 25, 2007)

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)
  • K014188 — NEW PROPHY POWDER (March 15, 2002)
  • K014252 — JETSTREAM (February 19, 2002)
  • K014249 — JETPOLISHER (February 19, 2002)

FDA data resources