FDA · official record K102635Substantially Equivalent

APOLONIA LASER IMPLANT SYSTEM

Name: APOLONIA LASER IMPLANT SYSTEM — FDA K102635
Creator: Csm Implant Co., Ltd.
Keywords: APOLONIA LASER IMPLANT SYSTEM, APOLONIA LASER IMPLANT SYSTEM, K102635, DZE, FDA

United StatesDZECsm Implant Co., Ltd.

Verified

Official record identity

FDA application number: K102635
Decision date: March 22, 2011
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Csm Implant Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2010-09-13
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.