FDA 510(k)

DSP Implant System

K-Number: K192839 · 2021-02-11

Decision Date2021-02-11

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DSP Implant System is the device name listed in this FDA 510(k) record. The listed applicant is D.S.P Industrial Eireli. It received FDA 510(k) clearance on 2021-02-11 under 510(k) number K192839. 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 DSP Implant System?

DSP Implant System is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is D.S.P Industrial Eireli. The 510(k) number is K192839.

When did DSP Implant System receive FDA 510(k) clearance?

DSP Implant System received FDA 510(k) clearance on 2021-02-11, under 510(k) number K192839.

Who is the listed applicant for DSP Implant System?

The FDA 510(k) record lists D.S.P Industrial Eireli as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSP Implant System?

The FDA product code for DSP Implant System is DZE.

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 AB K252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

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