Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

S-Mono

K-Number: K221317 · 2023-01-13

ApplicantShinhung Mst Co., Ltd.
Decision Date2023-01-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S-Mono is a medical device manufactured by Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under approval number K221317. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-Mono?

S-Mono is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Shinhung Mst Co., Ltd.. The 510(k) number is K221317.

When was S-Mono approved by the FDA?

S-Mono received FDA 510(k) clearance on 2023-01-13, under approval number K221317.

What company makes S-Mono?

S-Mono is manufactured by Shinhung Mst Co., Ltd..

What is the FDA product code for S-Mono?

The FDA product code for S-Mono is DZE.

Other Devices by Shinhung Mst Co., Ltd.

K160106LUNA DENTAL IMPLANT SYSTEM K162867MagDen Dental Implant System K200189Luna Dental Implant System- Healing Abutment K221752Stella K223395Luna Dental Implant System

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑