FDA · official record K955406Substantially Equivalent

SCAN WHITE 12 ML

Name: SCAN WHITE 12 ML — FDA K955406
Creator: Vident
Keywords: SCAN WHITE 12 ML, SCAN WHITE 12 ML, K955406, ELW, FDA

United StatesELWVident

Verified

Official record identity

FDA application number: K955406
Decision date: December 28, 1995
Published decision: Substantially Equivalent

Classification

Product code: ELW

Published parties

Applicant: Vident

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-11-27
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3660

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.