Cleared Traditional

K935687 - NIL
(FDA 510(k) Clearance)

K935687 · Dentalsafe Systems Pty., Ltd. · Dental device

Feb 1994

Decision

66d

Days

Class 1

Risk

K935687 is an FDA 510(k) clearance for the NIL. This device is classified as a Mirror, Mouth (Class I - General Controls, product code EAX).

Submitted by Dentalsafe Systems Pty., Ltd. (Sydney, Australia, AU). The FDA issued a Cleared decision on February 3, 1994, 66 days after receiving the submission on November 29, 1993.

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

Submission Details

510(k) Number	K935687 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 29, 1993
Decision Date	February 03, 1994
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement