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510(k) K862384

SCHEIN AP-1 AIR POLISHING UNIT by Henry Schein, Inc. — Product Code KOJ

K862384 is an FDA 510(k) premarket notification submitted by Henry Schein, Inc. for the device "SCHEIN AP-1 AIR POLISHING UNIT". The FDA issued a decision of Substantially Equivalent on November 7, 1986. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Henry Schein, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1986
Date Received
June 24, 1986
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 Henry Schein, Inc.

  • K041580 — IMAGERAYI (June 29, 2004)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 1984)
  • K834055 — VANADIUM EXCAVATORS SIZES 0-6 (February 21, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)
  • K781592 — SURGICAL ASPIRATOR TIPS (December 4, 1978)

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