FDA · official record K090519Substantially Equivalent

VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247

Name: VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 — FDA K090519
Creator: 3M Company
Keywords: VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247, VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247, K090519, LBH, FDA

United StatesLBH3M Company

Verified

Official record identity

FDA application number: K090519
Decision date: April 15, 2009
Published decision: Substantially Equivalent

Classification

Product code: LBH

Published parties

Applicant: 3M Company

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2009-02-26
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3260

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.