Cleared Traditional

K941065 - DEOX, OXYGEN BARRIER VISCOUS SOLUTION (FDA 510(k) Clearance)

K941065 · Ultradent Products, Inc. · Dental device

Jun 1994

Decision

100d

Days

Class 2

Risk

K941065 is an FDA 510(k) clearance for the DEOX, OXYGEN BARRIER VISCOUS SOLUTION. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on June 16, 1994, 100 days after receiving the submission on March 8, 1994.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K941065 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 1994
Decision Date	June 16, 1994
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement