Cleared Traditional

K960506 - A-DEC PERFORMER CONTROL UNIT (FDA 510(k) Clearance)

K960506 · A-Dec, Inc. · Dental device
Mar 1996
Decision
49d
Days
Class 1
Risk

K960506 is an FDA 510(k) clearance for the A-DEC PERFORMER CONTROL UNIT. 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 March 25, 1996, 49 days after receiving the submission on February 5, 1996.

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

Submission Details

510(k) Number K960506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date March 25, 1996
Days to Decision 49 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