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FDA 510(k)

Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw

K-Number: K231100 · 2024-08-23

ApplicantProimtech Saglik Urunleri Anonim Sirketi
Decision Date2024-08-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw is the device name listed in this FDA 510(k) record. The listed applicant is Proimtech Saglik Urunleri Anonim Sirketi. It received FDA 510(k) clearance on 2024-08-23 under 510(k) number K231100. 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 Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw?

Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is Proimtech Saglik Urunleri Anonim Sirketi. The 510(k) number is K231100.

When did Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw receive FDA 510(k) clearance?

Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw received FDA 510(k) clearance on 2024-08-23, under 510(k) number K231100.

Who is the listed applicant for Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw?

The FDA 510(k) record lists Proimtech Saglik Urunleri Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw?

The FDA product code for Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw is DZE.

Related Clinical Trials

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.

NCT07687615Cover Screw vs Healing Abutment on OsseointegrationCOMPLETEDNCT04695899Zirconia Implants for Replacement of a Single ToothACTIVE_NOT_RECRUITINGNCT06636136Transtibial OsseointegrationRECRUITINGNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07557836Comparative Clinical Study of Implant Stability and Peri-implant Bone Loss in Two Implant DesignsCOMPLETEDNCT07624331Volumetric Analysis of Peri-Implant Soft Tissue Changes Between Polyethereketone(PEEK) Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant RestorationsRECRUITING

Other records listing Proimtech Saglik Urunleri Anonim Sirketi 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.

K233419GBR SystemK231502Mini Screws

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

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

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