FDA · official record K132825Substantially Equivalent

RETROMTA-ORTHOMTA II

Name: RETROMTA-ORTHOMTA II — FDA K132825
Creator: Biomta
Keywords: RETROMTA-ORTHOMTA II, RETROMTA-ORTHOMTA II, K132825, KIF, FDA

United StatesKIFBiomta

Verified

Official record identity

FDA application number: K132825
Decision date: April 10, 2014
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Biomta

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2013-09-09
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3820

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.