Cleared Traditional

K962665 - A-DEC SELF-CONTAINED WATER SYSTEM (FDA 510(k) Clearance)

K962665 · A-Dec, Inc. · Dental device
Aug 1996
Decision
44d
Days
Class 1
Risk

K962665 is an FDA 510(k) clearance for the A-DEC SELF-CONTAINED WATER SYSTEM. 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 August 22, 1996, 44 days after receiving the submission on July 9, 1996.

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

Submission Details

510(k) Number K962665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1996
Decision Date August 22, 1996
Days to Decision 44 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