FDA · official record K875091Substantially Equivalent

ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT

Name: ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT — FDA K875091
Creator: Mission White Dental, Inc.
Keywords: ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT, ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT, K875091, EBC, FDA

United StatesEBCMission White Dental, Inc.

Verified

Official record identity

FDA application number: K875091
Decision date: February 29, 1988
Published decision: Substantially Equivalent

Classification

Product code: EBC

Published parties

Applicant: Mission White Dental, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1987-12-10
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3765

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.