Cleared Traditional

K000966 - 4631 DUO DELIVERY SYSTEM (FDA 510(k) Clearance)

K000966 · A-Dec, Inc. · Dental device
May 2000
Decision
37d
Days
Class 1
Risk

K000966 is an FDA 510(k) clearance for the 4631 DUO DELIVERY 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 May 3, 2000, 37 days after receiving the submission on March 27, 2000.

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

Submission Details

510(k) Number K000966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2000
Decision Date May 03, 2000
Days to Decision 37 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