Home / 510(k) Clearances / K970589

510(k) K970589

MICROETCHER AP by Danville Engineering, Inc. — Product Code KOJ

K970589 is an FDA 510(k) premarket notification submitted by Danville Engineering, Inc. for the device "MICROETCHER AP". The FDA issued a decision of Substantially Equivalent on September 17, 1997. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Danville Engineering, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1997
Date Received
February 18, 1997
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 Danville Engineering, Inc.

  • K955445 — CARIES FINDER (February 8, 1996)
  • K953504 — MICROPRIME (October 3, 1995)
  • K902836 — MICROETCHER (November 20, 1990)

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