FDA · official record K983876Substantially Equivalent

MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC

Name: MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC — FDA K983876
Creator: Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind
Keywords: MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC, MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC, K983876, EBI, FDA

United StatesEBIMycone Dental Supply Co., Inc. (A/K/A Keystone Ind

Verified

Official record identity

FDA application number: K983876
Decision date: December 16, 1998
Published decision: Substantially Equivalent

Classification

Product code: EBI

Published parties

Applicant: Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1998-11-02
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3760

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.