FDA · official record K143591Substantially Equivalent

Dorsal Appliance

Name: Dorsal Appliance — FDA K143591
Creator: Gergens Orthodontic Lab
Keywords: Dorsal Appliance, Dorsal Appliance, K143591, LRK, FDA

United StatesLRKGergens Orthodontic Lab

Verified

Official record identity

FDA application number: K143591
Decision date: April 15, 2015
Published decision: Substantially Equivalent

Classification

Product code: LRK

Published parties

Applicant: Gergens Orthodontic Lab

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2014-12-18
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5570

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.