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FDA 510(k)

OsteoCentric Dental Implant System

K-Number: K230242 · 2023-10-05

ApplicantOsteoCentric Technologies
Decision Date2023-10-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OsteoCentric Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K230242. 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 OsteoCentric Dental Implant System?

OsteoCentric Dental Implant System is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is OsteoCentric Technologies. The 510(k) number is K230242.

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

OsteoCentric Dental Implant System received FDA 510(k) clearance on 2023-10-05, under 510(k) number K230242.

Who is the listed applicant for OsteoCentric Dental Implant System?

The FDA 510(k) record lists OsteoCentric Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCentric Dental Implant System?

The FDA product code for OsteoCentric Dental Implant System is DZE.

Other records listing OsteoCentric Technologies 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.

K250520OsteoCentric Navigated Instruments SystemK251913OsteoCentric® UnifiMI® TCS Plating SystemK250494The OsteoCentric Bone Plate and Screw SystemK242691OsteoCentric Technologies Cannulated Fasteners and NutsK230226Integrity-SI® Fusion SystemK230595OsteoCentric ACL Fixation 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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