FDA · official record K140602Substantially Equivalent

FLASH PENTA MB QUICK, FLASH MB QUICK

Name: FLASH PENTA MB QUICK, FLASH MB QUICK — FDA K140602
Creator: 3M Espe AG
Keywords: FLASH PENTA MB QUICK, FLASH MB QUICK, FLASH PENTA MB QUICK, FLASH MB QUICK, K140602, ELW, FDA

United StatesELW3M Espe AG

Verified

Official record identity

FDA application number: K140602
Decision date: June 05, 2014
Published decision: Substantially Equivalent

Classification

Product code: ELW

Published parties

Applicant: 3M Espe AG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2014-03-10
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3660

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.