FDA · official record K070373Substantially Equivalent

APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W

Name: APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W — FDA K070373
Creator: Apoza Enterprise Co., Ltd.
Keywords: APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W, APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W, K070373, EBZ, FDA

United StatesEBZApoza Enterprise Co., Ltd.

Verified

Official record identity

FDA application number: K070373
Decision date: March 02, 2007
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Apoza Enterprise Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2007-02-08
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6070

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.