FDA · official record K210826Substantially Equivalent

Healing Abutment, Cover Screw

Name: Healing Abutment, Cover Screw — FDA K210826
Creator: Megagen Implant Co., Ltd.
Keywords: Healing Abutment, Cover Screw, Healing Abutment, Cover Screw, K210826, NHA, FDA

United StatesNHAMegagen Implant Co., Ltd.

Verified

Official record identity

FDA application number: K210826
Decision date: February 03, 2022
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Megagen Implant Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2021-03-19
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

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.