FDA · official record K101481Substantially Equivalent

BIOMERS TRANSLUCENT ORTHODONTIC BRACKET

Name: BIOMERS TRANSLUCENT ORTHODONTIC BRACKET — FDA K101481
Creator: Biomers Products, LLC
Keywords: BIOMERS TRANSLUCENT ORTHODONTIC BRACKET, BIOMERS TRANSLUCENT ORTHODONTIC BRACKET, K101481, NJM, FDA

United StatesNJMBiomers Products, LLC

Verified

Official record identity

FDA application number: K101481
Decision date: June 23, 2010
Published decision: Substantially Equivalent

Classification

Product code: NJM

Published parties

Applicant: Biomers Products, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2010-05-28
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.