FDA · official record K931615Substantially Equivalent

NITE-GUIDE

Name: NITE-GUIDE — FDA K931615
Creator: ORTHO-TAIN, Inc.
Keywords: NITE-GUIDE, NITE-GUIDE, K931615, KMY, FDA

United StatesKMYORTHO-TAIN, Inc.

Verified

Official record identity

FDA application number: K931615
Decision date: April 14, 1995
Published decision: Substantially Equivalent

Classification

Product code: KMY

Published parties

Applicant: ORTHO-TAIN, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1993-04-01
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.5525

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.