Cleared Traditional

K940785 - MOUTH PROPS
(FDA 510(k) Clearance)

K940785 · Worldwide Dental, Inc. · Dental device

Oct 1994

Decision

225d

Days

Class 1

Risk

K940785 is an FDA 510(k) clearance for the MOUTH PROPS. This device is classified as a Accessories, Retractor, Dental (Class I - General Controls, product code EIF).

Submitted by Worldwide Dental, Inc. (Clearwater, US). The FDA issued a Cleared decision on October 5, 1994, 225 days after receiving the submission on February 22, 1994.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K940785 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 22, 1994
Decision Date	October 05, 1994
Days to Decision	225 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement