FDA · official record K791716Substantially Equivalent

PLAQUE-X DENTURE CLEANSER

Name: PLAQUE-X DENTURE CLEANSER — FDA K791716
Creator: Noxell
Keywords: PLAQUE-X DENTURE CLEANSER, PLAQUE-X DENTURE CLEANSER, K791716, JER, FDA

United StatesJERNoxell

Verified

Official record identity

FDA application number: K791716
Decision date: October 23, 1979
Published decision: Substantially Equivalent

Classification

Product code: JER

Published parties

Applicant: Noxell

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1979-08-31
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.3530

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.