FDA · official record K123468Substantially Equivalent

DEMI ULTRA

Name: DEMI ULTRA — FDA K123468
Creator: Kerr Corporation
Keywords: DEMI ULTRA, DEMI ULTRA, K123468, EBZ, FDA

United StatesEBZKerr Corporation

Verified

Official record identity

FDA application number: K123468
Decision date: March 20, 2013
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Kerr Corporation

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2012-11-09
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6070

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.