510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862384Substantially Equivalent

Schein Ap-1 Air Polishing Unit

Henry Schein, Inc., Port Washington NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862384 is the FDA 510(k) clearance record for SCHEIN AP-1 AIR POLISHING UNIT, a class II device, cleared for Henry Schein, Inc. on under FDA product code KOJ (Airbrush). FDA records list 8 510(k) clearances for Henry Schein, Inc., from to . As of , FDA records show no recalls naming K862384.

Clearance record

Decision date
Received
(136 days to decision)
Product code
KOJ Airbrush
Regulation
21 CFR 872.6080
Device class
Class II
Review panel
Dental
Applicant
Henry Schein, Inc. 5 Harbor Park Dr., Port Washington NY
Third party review
No

Clearances, product code KOJ

Trailing 12 months

FDA records hold no clearances under product code KOJ in the trailing twelve months.

FDA records show no clearances under product code KOJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260