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FDA 510(k)

S.I.N. Implant System

K-Number: K170392 · 2017-12-01

ApplicantS.I.N. – Sistema DE Implante Nacional S.A.
Decision Date2017-12-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S.I.N. Implant System is the device name listed in this FDA 510(k) record. The listed applicant is S.I.N. – Sistema DE Implante Nacional S.A.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K170392. 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. Implant System?

S.I.N. Implant System is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is S.I.N. – Sistema DE Implante Nacional S.A.. The 510(k) number is K170392.

When did S.I.N. Implant System receive FDA 510(k) clearance?

S.I.N. Implant System received FDA 510(k) clearance on 2017-12-01, under 510(k) number K170392.

Who is the listed applicant for S.I.N. Implant System?

The FDA 510(k) record lists S.I.N. – Sistema DE Implante Nacional S.A. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for S.I.N. Implant System is DZE.

Other records listing S.I.N. – Sistema DE Implante Nacional S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240609S.I.N. Dental Implant SystemK241378S.I.N. Instrument KitsK232821S.I.N. Dental Implant SystemK231127S.I.N. Dental Implant SystemK230069S.I.N. Dental Implant SystemK221453S.I.N. Dental Implant System

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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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