FDA · official record K791067Substantially Equivalent

SCI-PHARM PAINT-ON RESTORATIVE

Name: SCI-PHARM PAINT-ON RESTORATIVE — FDA K791067
Creator: Scientific Pharmaceuticals, Inc.
Keywords: SCI-PHARM PAINT-ON RESTORATIVE, SCI-PHARM PAINT-ON RESTORATIVE, K791067, EBD, FDA

United StatesEBDScientific Pharmaceuticals, Inc.

Verified

Official record identity

FDA application number: K791067
Decision date: August 10, 1979
Published decision: Substantially Equivalent

Classification

Product code: EBD

Published parties

Applicant: Scientific Pharmaceuticals, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1979-06-12
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3310

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.