510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970484Substantially Equivalent

Accu-Prep

Bisco, Inc., Itasca IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970484 is the FDA 510(k) clearance record for ACCU-PREP, a class II device, cleared for Bisco, Inc. on under FDA product code KOJ (Airbrush). FDA records list 18 510(k) clearances for Bisco, Inc., from to . As of , FDA records show no recalls naming K970484.

Clearance record

Decision date
Received
(141 days to decision)
Product code
KOJ Airbrush
Regulation
21 CFR 872.6080
Device class
Class II
Review panel
Dental
Applicant
Bisco, Inc. 1500 W. Thorndale Ave., Itasca IL
510(k) summary
Summary
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