Cleared Traditional

K935325 - A-DEC CASCADE 3072 WALLMOUNT (FDA 510(k) Clearance)

Apr 1994
Decision
167d
Days
Class 1
Risk

K935325 is an FDA 510(k) clearance for the A-DEC CASCADE 3072 WALLMOUNT. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on April 21, 1994, 167 days after receiving the submission on November 5, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K935325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1993
Decision Date April 21, 1994
Days to Decision 167 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.6640