FDA · official record K180703Substantially Equivalent

VITA YZ ST and VITA YZ XT

Name: VITA YZ ST and VITA YZ XT — FDA K180703
Creator: Vita Zahnfabrik H.Rauter GmbH Co.
Keywords: VITA YZ ST and VITA YZ XT, VITA YZ ST and VITA YZ XT, K180703, EIH, FDA

United StatesEIHVita Zahnfabrik H.Rauter GmbH Co.

Verified

Official record identity

FDA application number: K180703
Decision date: August 01, 2018
Published decision: Substantially Equivalent

Classification

Product code: EIH

Published parties

Applicant: Vita Zahnfabrik H.Rauter GmbH Co.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2018-03-19
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6660

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.