FDA · official record K042872Substantially Equivalent

RONDOFLEX PLUS 360

Name: RONDOFLEX PLUS 360 — FDA K042872
Creator: Kavo America Corporation
Keywords: RONDOFLEX PLUS 360, RONDOFLEX PLUS 360, K042872, KOJ, FDA

United StatesKOJKavo America Corporation

Verified

Official record identity

FDA application number: K042872
Decision date: November 23, 2004
Published decision: Substantially Equivalent

Classification

Product code: KOJ

Published parties

Applicant: Kavo America Corporation

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2004-10-18
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6080

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.