FDA · official record K200189Substantially Equivalent

Luna Dental Implant System- Healing Abutment

Name: Luna Dental Implant System- Healing Abutment — FDA K200189
Creator: Shinhung Mst Co., Ltd.
Keywords: Luna Dental Implant System- Healing Abutment, Luna Dental Implant System- Healing Abutment, K200189, NHA, FDA

United StatesNHAShinhung Mst Co., Ltd.

Verified

Official record identity

FDA application number: K200189
Decision date: February 26, 2020
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Shinhung Mst Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2020-01-27
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.