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FDA 510(k)

SNUCONE Bone Level Implant System

K-Number: K210354 · 2022-07-13

ApplicantSnucone Co., Ltd.
Decision Date2022-07-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SNUCONE Bone Level Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Snucone Co., Ltd.. It received FDA 510(k) clearance on 2022-07-13 under 510(k) number K210354. 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 SNUCONE Bone Level Implant System?

SNUCONE Bone Level Implant System is a medical device that received FDA 510(k) clearance on 2022-07-13. The listed applicant is Snucone Co., Ltd.. The 510(k) number is K210354.

When did SNUCONE Bone Level Implant System receive FDA 510(k) clearance?

SNUCONE Bone Level Implant System received FDA 510(k) clearance on 2022-07-13, under 510(k) number K210354.

Who is the listed applicant for SNUCONE Bone Level Implant System?

The FDA 510(k) record lists Snucone Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SNUCONE Bone Level Implant System?

The FDA product code for SNUCONE Bone Level Implant System 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.

NCT02569671Bone Level Tapered Multi-Center StudyCOMPLETEDNCT03908177Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.COMPLETEDNCT04251377Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint InfectionACTIVE_NOT_RECRUITINGNCT04741594Osseodensification and Implant Survival and SuccessCOMPLETEDNCT06012071Two-piece Zirconia Implants With Two Various PlatformsRECRUITINGNCT06293352Real-component vs All-cement Articulating Spacers for Periprosthetic Knee InfectionRECRUITING

Other records listing Snucone Co., Ltd. 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.

K222792SNUCONE Tissue Level 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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