FDA · official record K880684Substantially Equivalent

XR PRIMER

Name: XR PRIMER — FDA K880684
Creator: Kerr Corporation (Danbury)
Keywords: XR PRIMER, XR PRIMER, K880684, KLE, FDA

United StatesKLEKerr Corporation (Danbury)

Verified

Official record identity

FDA application number: K880684
Decision date: May 11, 1988
Published decision: Substantially Equivalent

Classification

Product code: KLE

Published parties

Applicant: Kerr Corporation (Danbury)

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1988-02-19
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3200

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.