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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 a medical device manufactured by Proimtech Saglik Urunleri Anonim Sirketi. It received FDA 510(k) clearance on 2024-08-23 under approval 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. It is manufactured by Proimtech Saglik Urunleri Anonim Sirketi. The 510(k) number is K231100.

When was Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw approved by the FDA?

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

What company makes 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 manufactured by Proimtech Saglik Urunleri Anonim Sirketi.

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

NCT07615361 Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy ENROLLING_BY_INVITATION NCT07608744 Alloplastic Graft vs Xenograft for Horizontal Alveolar Ridge Augmentation COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT02161874 Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System COMPLETED NCT07588789 The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group ACTIVE_NOT_RECRUITING NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING

Other Devices by Proimtech Saglik Urunleri Anonim Sirketi

K231502Mini Screws K233419GBR System

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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