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FDA 510(k)

S.I.N. Dental Implant System

K-Number: K203725 · 2021-06-23

ApplicantS.I.N. - Sistema DE Implante Nacional S.A.
Decision Date2021-06-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S.I.N. Dental Implant System is a medical device manufactured by S.I.N. - Sistema DE Implante Nacional S.A.. It received FDA 510(k) clearance on 2021-06-23 under approval number K203725. 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.I.N. Dental Implant System?

S.I.N. Dental Implant System is a medical device that received FDA 510(k) clearance on 2021-06-23. It is manufactured by S.I.N. - Sistema DE Implante Nacional S.A.. The 510(k) number is K203725.

When was S.I.N. Dental Implant System approved by the FDA?

S.I.N. Dental Implant System received FDA 510(k) clearance on 2021-06-23, under approval number K203725.

What company makes S.I.N. Dental Implant System?

S.I.N. Dental Implant System is manufactured by S.I.N. - Sistema DE Implante Nacional S.A..

What is the FDA product code for S.I.N. Dental Implant System?

The FDA product code for S.I.N. 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)

Other Devices by S.I.N. - Sistema DE Implante Nacional S.A.

K200992S.I.N. Dental Implant System K201688S.I.N. Instrument Kits K193096S.I.N. Dental Implant System K212404S.I.N. Instrument Kits K211921S.I.N. Dental Implant System K222231S.I.N. Dental Implant System

View all 12 devices →

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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