FDA · official record K782068Substantially Equivalent

MVS UNIT, MODEL SEU-8 AND DEU-8, 80

Name: MVS UNIT, MODEL SEU-8 AND DEU-8, 80 — FDA K782068
Creator: Dentsply Intl.
Keywords: MVS UNIT, MODEL SEU-8 AND DEU-8, 80, MVS UNIT, MODEL SEU-8 AND DEU-8, 80, K782068, EHZ, FDA

United StatesEHZDentsply Intl.

Verified

Official record identity

FDA application number: K782068
Decision date: January 26, 1979
Published decision: Substantially Equivalent

Classification

Product code: EHZ

Published parties

Applicant: Dentsply Intl.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1978-12-13
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

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.