Cleared Traditional

K942668 - O-TRAY IMPRESSION TRAYS
(FDA 510(k) Clearance)

K942668 · Dentauraum, Inc. · Dental device

Jul 1994

Decision

46d

Days

Class 1

Risk

K942668 is an FDA 510(k) clearance for the O-TRAY IMPRESSION TRAYS. This device is classified as a Tray, Impression, Preformed (Class I - General Controls, product code EHY).

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on July 22, 1994, 46 days after receiving the submission on June 6, 1994.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6880.

Submission Details

510(k) Number	K942668 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 1994
Decision Date	July 22, 1994
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement