FDA · official record K160140Substantially Equivalent

DENTRIa series

Name: DENTRIa series — FDA K160140
Creator: Hdx Will Corp.
Keywords: DENTRIa series, DENTRIa series, K160140, OAS, FDA

United StatesOASHdx Will Corp.

Verified

Official record identity

FDA application number: K160140
Decision date: September 30, 2016
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Hdx Will Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2016-01-21
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

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.