FDA · official record K093453Substantially Equivalent

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

Name: MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM — FDA K093453
Creator: Schick Technologies, Inc.
Keywords: MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM, MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM, K093453, EAP, FDA

United StatesEAPSchick Technologies, Inc.

Verified

Official record identity

FDA application number: K093453
Decision date: November 30, 2009
Published decision: Substantially Equivalent

Classification

Product code: EAP

Published parties

Applicant: Schick Technologies, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2009-11-05
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1810

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.