Cleared Traditional

K893219 - MATRX DENTAL UNIT
(FDA 510(k) Clearance)

K893219 · Matrix Medica, Inc. · Dental

Aug 1989

Decision

102d

Days

Class 1

Risk

K893219 is an FDA 510(k) clearance for the MATRX DENTAL UNIT, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on August 7, 1989, 102 days after receiving the submission on April 27, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K893219 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 1989
Decision Date	August 07, 1989
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—