FDA · official record K103537Substantially Equivalent

ET III SA ULTRA WIDE SYSTEM

Name: ET III SA ULTRA WIDE SYSTEM — FDA K103537
Creator: Hiossen, Inc.
Keywords: ET III SA ULTRA WIDE SYSTEM, ET III SA ULTRA WIDE SYSTEM, K103537, DZE, FDA

United StatesDZEHiossen, Inc.

Verified

Official record identity

FDA application number: K103537
Decision date: March 10, 2011
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Hiossen, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2010-12-02
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

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.