Cleared Traditional

MU System

K222976 · Dentis Co., Ltd. · Dental

Jan 2023

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K222976 is an FDA 510(k) clearance for the MU System, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on January 12, 2023, 106 days after receiving the submission on September 28, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K222976 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2022
Decision Date	January 12, 2023
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.