FDA · official record K021613Substantially Equivalent

NIVEOUS LIQUID DAM

Name: NIVEOUS LIQUID DAM — FDA K021613
Creator: Shofu Dental Corp.
Keywords: NIVEOUS LIQUID DAM, NIVEOUS LIQUID DAM, K021613, EIE, FDA

United StatesEIEShofu Dental Corp.

Verified

Official record identity

FDA application number: K021613
Decision date: June 20, 2002
Published decision: Substantially Equivalent

Classification

Product code: EIE

Published parties

Applicant: Shofu Dental Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2002-05-16
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6300

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.