FDA · official record K122467Substantially Equivalent

3M TRUE DEFINITION SCANNER

Name: 3M TRUE DEFINITION SCANNER — FDA K122467
Creator: 3M Company
Keywords: 3M TRUE DEFINITION SCANNER, 3M TRUE DEFINITION SCANNER, K122467, NOF, FDA

United StatesNOF3M Company

Verified

Official record identity

FDA application number: K122467
Decision date: November 20, 2012
Published decision: Substantially Equivalent

Classification

Product code: NOF

Published parties

Applicant: 3M Company

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2012-08-13
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3661

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.