Cleared Traditional

K970484 - ACCU-PREP (FDA 510(k) Clearance)

K970484 · Bisco, Inc. · Dental device
Jul 1997
Decision
141d
Days
Class 2
Risk

K970484 is an FDA 510(k) clearance for the ACCU-PREP. This device is classified as a Airbrush (Class II - Special Controls, product code KOJ).

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on July 1, 1997, 141 days after receiving the submission on February 10, 1997.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K970484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date July 01, 1997
Days to Decision 141 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KOJ — Airbrush
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.6080