FDA · official record K070537Substantially Equivalent

ZIRBLOCK

Name: ZIRBLOCK — FDA K070537
Creator: Cdl Technologies, Inc.
Keywords: ZIRBLOCK, ZIRBLOCK, K070537, EIH, FDA

United StatesEIHCdl Technologies, Inc.

Verified

Official record identity

FDA application number: K070537
Decision date: April 30, 2007
Published decision: Substantially Equivalent

Classification

Product code: EIH

Published parties

Applicant: Cdl Technologies, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-02-26
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6660

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.