Cleared Traditional

K896532 - DENTAL DELIVERY SYSTEM
(FDA 510(k) Clearance)

K896532 · Dentech Corp. · Dental

Feb 1990

Decision

90d

Days

Class 1

Risk

K896532 is an FDA 510(k) clearance for the DENTAL DELIVERY SYSTEM, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Dentech Corp. (Sumas, US). The FDA issued a Cleared decision on February 12, 1990, 90 days after receiving the submission on November 14, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K896532 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 1989
Decision Date	February 12, 1990
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—