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FDA 510(k)

PREMIUM Implant Systems SHELTA Implant Systems

K-Number: K161989 · 2018-02-01

ApplicantSweden & Martina S.P.A.
Decision Date2018-02-01
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIUM Implant Systems SHELTA Implant Systems is a medical device manufactured by Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2018-02-01 under approval number K161989. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIUM Implant Systems SHELTA Implant Systems?

PREMIUM Implant Systems SHELTA Implant Systems is a medical device that received FDA 510(k) clearance on 2018-02-01. It is manufactured by Sweden & Martina S.P.A.. The 510(k) number is K161989.

When was PREMIUM Implant Systems SHELTA Implant Systems approved by the FDA?

PREMIUM Implant Systems SHELTA Implant Systems received FDA 510(k) clearance on 2018-02-01, under approval number K161989.

What company makes PREMIUM Implant Systems SHELTA Implant Systems?

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

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

The FDA product code for PREMIUM Implant Systems SHELTA Implant Systems is NHA.

Related Clinical Trials

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

K162004PREMIUM Implant Systems SHELTA Implant Systems K172560PREMIUM ONE Implant Systems K162028PREMIUM - SHELTA Prosthetic Components K180365PRAMA White Implant Systems K182084Sweden & Martina Surgical Tray (Model ZSHORTY-INT) K222640Sweden & Martina Surgical Trays

View all 7 devices →

Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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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