FDA · official record K060646Substantially Equivalent

BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855

Name: BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 — FDA K060646
Creator: Monitex Industrial Co., Ltd.
Keywords: BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855, BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855, K060646, EBZ, FDA

United StatesEBZMonitex Industrial Co., Ltd.

Verified

Official record identity

FDA application number: K060646
Decision date: April 21, 2006
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Monitex Industrial Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2006-03-10
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.