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FDA 510(k)

S-Plant Dental Implant System

K-Number: K231429 · 2023-12-18

ApplicantIdis Co., Ltd.
Decision Date2023-12-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S-Plant Dental Implant System is a medical device manufactured by Idis Co., Ltd.. It received FDA 510(k) clearance on 2023-12-18 under approval number K231429. 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-Plant Dental Implant System?

S-Plant Dental Implant System is a medical device that received FDA 510(k) clearance on 2023-12-18. It is manufactured by Idis Co., Ltd.. The 510(k) number is K231429.

When was S-Plant Dental Implant System approved by the FDA?

S-Plant Dental Implant System received FDA 510(k) clearance on 2023-12-18, under approval number K231429.

What company makes S-Plant Dental Implant System?

S-Plant Dental Implant System is manufactured by Idis Co., Ltd..

What is the FDA product code for S-Plant Dental Implant System?

The FDA product code for S-Plant Dental Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

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.

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