FDA · official record K100248Substantially Equivalent

DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S

Name: DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S — FDA K100248
Creator: Drfp , Ltd.
Keywords: DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S, DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S, K100248, KIF, FDA

United StatesKIFDrfp , Ltd.

Verified

Official record identity

FDA application number: K100248
Decision date: October 22, 2010
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Drfp , Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2010-01-27
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3820

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.