FDA · official record K191382Substantially Equivalent

IPS e.max CAD Abutment Solutions- extra systems

Name: IPS e.max CAD Abutment Solutions- extra systems — FDA K191382
Creator: Ivoclar Vivadent, AG
Keywords: IPS e.max CAD Abutment Solutions- extra systems, IPS e.max CAD Abutment Solutions- extra systems, K191382, NHA, FDA

United StatesNHAIvoclar Vivadent, AG

Verified

Official record identity

FDA application number: K191382
Decision date: August 26, 2019
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Ivoclar Vivadent, AG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2019-05-23
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

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.