FDA · official record K202617Substantially Equivalent

Metapex Plus

Name: Metapex Plus — FDA K202617
Creator: Meta Biomed Co., Ltd.
Keywords: Metapex Plus, Metapex Plus, K202617, KIF, FDA

United StatesKIFMeta Biomed Co., Ltd.

Verified

Official record identity

FDA application number: K202617
Decision date: April 14, 2021
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Meta Biomed Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2020-09-09
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3820

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.