FDA · official record K031658Substantially Equivalent

BENCO SPHERICAL

Name: BENCO SPHERICAL — FDA K031658
Creator: Southern Dental Industries, Inc.
Keywords: BENCO SPHERICAL, BENCO SPHERICAL, K031658, EJJ, FDA

United StatesEJJSouthern Dental Industries, Inc.

Verified

Official record identity

FDA application number: K031658
Decision date: July 29, 2003
Published decision: Substantially Equivalent

Classification

Product code: EJJ

Published parties

Applicant: Southern Dental Industries, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2003-05-28
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3070

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.