FDA · official record K001480Substantially Equivalent

AURECAST 40 B

Name: AURECAST 40 B — FDA K001480
Creator: Aurex SA (Pty) , Ltd.
Keywords: AURECAST 40 B, AURECAST 40 B, K001480, EJT, FDA

United StatesEJTAurex SA (Pty) , Ltd.

Verified

Official record identity

FDA application number: K001480
Decision date: June 21, 2000
Published decision: Substantially Equivalent

Classification

Product code: EJT

Published parties

Applicant: Aurex SA (Pty) , Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2000-05-11
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3060

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.