FDA · official record K130455Substantially Equivalent

430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES

Name: 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES — FDA K130455
Creator: Dentalez Group, Stardental Division
Keywords: 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES, 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES, K130455, EFB, FDA

United StatesEFBDentalez Group, Stardental Division

Verified

Official record identity

FDA application number: K130455
Decision date: September 25, 2013
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Dentalez Group, Stardental Division

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2013-02-22
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.