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FDA 510(k)

OsseOne Dental Implant System

K-Number: K182293 · 2019-02-15

ApplicantSynoross Dba Osseone
Decision Date2019-02-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OsseOne Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Synoross Dba Osseone. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K182293. 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 OsseOne Dental Implant System?

OsseOne Dental Implant System is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Synoross Dba Osseone. The 510(k) number is K182293.

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

OsseOne Dental Implant System received FDA 510(k) clearance on 2019-02-15, under 510(k) number K182293.

Who is the listed applicant for OsseOne Dental Implant System?

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

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

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

Other records listing Synoross Dba Osseone 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.

K233271OsseOne 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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