FDA · official record K202952Substantially Equivalent

Amber Mill Q Series & Amber Mill Direct Series

Name: Amber Mill Q Series & Amber Mill Direct Series — FDA K202952
Creator: Hass Corp.
Keywords: Amber Mill Q Series & Amber Mill Direct Series, Amber Mill Q Series & Amber Mill Direct Series, K202952, EIH, FDA

United StatesEIHHass Corp.

Verified

Official record identity

FDA application number: K202952
Decision date: August 26, 2021
Published decision: Substantially Equivalent

Classification

Product code: EIH

Published parties

Applicant: Hass Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2020-09-30
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.