Cleared Traditional

K931615 - NITE-GUIDE
(FDA 510(k) Clearance)

K931615 · Ortho-Tain, Inc. · Dental

Apr 1995

Decision

743d

Days

Class 1

Risk

K931615 is an FDA 510(k) clearance for the NITE-GUIDE. This device is classified as a Positioner, Tooth, Preformed (Class I — General Controls, product code KMY).

Submitted by Ortho-Tain, Inc. (Chicago, US). The FDA issued a Cleared decision on April 14, 1995, 743 days after receiving the submission on April 1, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5525.

Submission Details

510(k) Number	K931615 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 1993
Decision Date	April 14, 1995
Days to Decision	743 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF