FDA · official record K801860Substantially Equivalent

S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX

Name: S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX — FDA K801860
Creator: Pennwalt Corp.
Keywords: S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX, S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX, K801860, EJK, FDA

United StatesEJKPennwalt Corp.

Verified

Official record identity

FDA application number: K801860
Decision date: October 10, 1980
Published decision: Substantially Equivalent

Classification

Product code: EJK

Published parties

Applicant: Pennwalt Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1980-08-05
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3250

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.