FDA · official record K214091Substantially Equivalent

Dental Image Plate Scanner, Model DFC-4T-SMART

Name: Dental Image Plate Scanner, Model DFC-4T-SMART — FDA K214091
Creator: Hefei Dentafilm Medical Equipment Co., Ltd.
Keywords: Dental Image Plate Scanner, Model DFC-4T-SMART, Dental Image Plate Scanner, Model DFC-4T-SMART, K214091, MUH, FDA

United StatesMUHHefei Dentafilm Medical Equipment Co., Ltd.

Verified

Official record identity

FDA application number: K214091
Decision date: March 02, 2022
Published decision: Substantially Equivalent

Classification

Product code: MUH

Published parties

Applicant: Hefei Dentafilm Medical Equipment Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2021-12-28
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

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.