FDA · official record K081415Substantially Equivalent

DAMON 4CLEAR

Name: DAMON 4CLEAR — FDA K081415
Creator: Ormco Corp.
Keywords: DAMON 4CLEAR, DAMON 4CLEAR, K081415, NJM, FDA

United StatesNJMOrmco Corp.

Verified

Official record identity

FDA application number: K081415
Decision date: September 24, 2008
Published decision: Substantially Equivalent

Classification

Product code: NJM

Published parties

Applicant: Ormco Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2008-05-20
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5470

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.