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FDA 510(k)

S.I.N. Tapered Pro Conical Zygoma Implant System

K-Number: K251129 · 2025-11-07

ApplicantS.I.N. Implant System Ltda
Decision Date2025-11-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S.I.N. Tapered Pro Conical Zygoma Implant System is the device name listed in this FDA 510(k) record. The listed applicant is S.I.N. Implant System Ltda. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K251129. 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. Tapered Pro Conical Zygoma Implant System?

S.I.N. Tapered Pro Conical Zygoma Implant System is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is S.I.N. Implant System Ltda. The 510(k) number is K251129.

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

S.I.N. Tapered Pro Conical Zygoma Implant System received FDA 510(k) clearance on 2025-11-07, under 510(k) number K251129.

Who is the listed applicant for S.I.N. Tapered Pro Conical Zygoma Implant System?

The FDA 510(k) record lists S.I.N. Implant System Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.I.N. Tapered Pro Conical Zygoma Implant System?

The FDA product code for S.I.N. Tapered Pro Conical Zygoma Implant System is DZE.

Other records listing S.I.N. Implant System Ltda 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.

K252266S.I.N. Dental Implant SystemK251262S.I.N. Dental Implant SystemK251046S.I.N. Dental Implant System

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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