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FDA 510(k)

PREMIUM ONE Implant Systems

K-Number: K172560 · 2017-12-21

ApplicantSweden & Martina S.P.A.
Decision Date2017-12-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIUM ONE Implant Systems is a medical device manufactured by Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2017-12-21 under approval number K172560. 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 PREMIUM ONE Implant Systems?

PREMIUM ONE Implant Systems is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Sweden & Martina S.P.A.. The 510(k) number is K172560.

When was PREMIUM ONE Implant Systems approved by the FDA?

PREMIUM ONE Implant Systems received FDA 510(k) clearance on 2017-12-21, under approval number K172560.

What company makes PREMIUM ONE Implant Systems?

PREMIUM ONE Implant Systems is manufactured by Sweden & Martina S.P.A..

What is the FDA product code for PREMIUM ONE Implant Systems?

The FDA product code for PREMIUM ONE Implant Systems is DZE.

Related Clinical Trials

NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT07557836 Comparative Clinical Study of Implant Stability and Peri-implant Bone Loss in Two Implant Designs COMPLETED NCT02204618 Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study. COMPLETED NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED NCT07338864 A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults NOT_YET_RECRUITING

Other Devices by Sweden & Martina S.P.A.

K162004PREMIUM Implant Systems SHELTA Implant Systems K162028PREMIUM - SHELTA Prosthetic Components K161989PREMIUM Implant Systems SHELTA Implant Systems K180365PRAMA White Implant Systems K182084Sweden & Martina Surgical Tray (Model ZSHORTY-INT) K222640Sweden & Martina Surgical Trays

View all 7 devices →

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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