Cleared Traditional

K933166 - A-DEC 2611 ASSISTANT'S CART (FDA 510(k) Clearance)

Oct 1993
Decision
113d
Days
Class 1
Risk

K933166 is an FDA 510(k) clearance for the A-DEC 2611 ASSISTANT'S CART. 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 October 20, 1993, 113 days after receiving the submission on June 29, 1993.

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

Submission Details

510(k) Number K933166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date October 20, 1993
Days to Decision 113 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