FDA · official record K963205Substantially Equivalent

ALGINMAX, ORTHOCHROME

Name: ALGINMAX, ORTHOCHROME — FDA K963205
Creator: American Tooth Industries
Keywords: ALGINMAX, ORTHOCHROME, ALGINMAX, ORTHOCHROME, K963205, ELW, FDA

United StatesELWAmerican Tooth Industries

Verified

Official record identity

FDA application number: K963205
Decision date: October 29, 1996
Published decision: Substantially Equivalent

Classification

Product code: ELW

Published parties

Applicant: American Tooth Industries

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-08-09
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.