FDA · official record K063110Substantially Equivalent

CST61 HIGH SPEED TURBINE HANDPIECE

Name: CST61 HIGH SPEED TURBINE HANDPIECE — FDA K063110
Creator: Shanghai Dental Instrument Factory
Keywords: CST61 HIGH SPEED TURBINE HANDPIECE, CST61 HIGH SPEED TURBINE HANDPIECE, K063110, EFB, FDA

United StatesEFBShanghai Dental Instrument Factory

Verified

Official record identity

FDA application number: K063110
Decision date: October 26, 2006
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Shanghai Dental Instrument Factory

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2006-10-11
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

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.