FDA · official record K945462Substantially Equivalent

SUPER POLI-GRIP DENTURE ADHESIVE CREAM

Name: SUPER POLI-GRIP DENTURE ADHESIVE CREAM — FDA K945462
Creator: Block Drug Company, Inc.
Keywords: SUPER POLI-GRIP DENTURE ADHESIVE CREAM, SUPER POLI-GRIP DENTURE ADHESIVE CREAM, K945462, KOT, FDA

United StatesKOTBlock Drug Company, Inc.

Verified

Official record identity

FDA application number: K945462
Decision date: December 20, 1994
Published decision: Substantially Equivalent

Classification

Product code: KOT

Published parties

Applicant: Block Drug Company, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1994-11-07
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.3490

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.