FDA · official record K170578Substantially Equivalent

True Function Adjustable Herbst Appliances

Name: True Function Adjustable Herbst Appliances — FDA K170578
Creator: True Function Laboratory, Inc.
Keywords: True Function Adjustable Herbst Appliances, True Function Adjustable Herbst Appliances, K170578, LRK, FDA

United StatesLRKTrue Function Laboratory, Inc.

Verified

Official record identity

FDA application number: K170578
Decision date: November 24, 2017
Published decision: Substantially Equivalent

Classification

Product code: LRK

Published parties

Applicant: True Function Laboratory, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2017-02-27
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.