FDA · official record K113042Substantially Equivalent

REVOIS IMPLANT SYSTEM

Name: REVOIS IMPLANT SYSTEM — FDA K113042
Creator: Riemser Arzneimittel AG
Keywords: REVOIS IMPLANT SYSTEM, REVOIS IMPLANT SYSTEM, K113042, DZE, FDA

United StatesDZERiemser Arzneimittel AG

Verified

Official record identity

FDA application number: K113042
Decision date: March 08, 2013
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Riemser Arzneimittel AG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2011-10-12
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.