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FDA 510(k)

PREMIUM - SHELTA Prosthetic Components

K-Number: K162028 · 2017-03-24

ApplicantSweden & Martina S.P.A.
Decision Date2017-03-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIUM - SHELTA Prosthetic Components is a medical device manufactured by Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2017-03-24 under approval number K162028. 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 - SHELTA Prosthetic Components?

PREMIUM - SHELTA Prosthetic Components is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Sweden & Martina S.P.A.. The 510(k) number is K162028.

When was PREMIUM - SHELTA Prosthetic Components approved by the FDA?

PREMIUM - SHELTA Prosthetic Components received FDA 510(k) clearance on 2017-03-24, under approval number K162028.

What company makes PREMIUM - SHELTA Prosthetic Components?

PREMIUM - SHELTA Prosthetic Components is manufactured by Sweden & Martina S.P.A..

What is the FDA product code for PREMIUM - SHELTA Prosthetic Components?

The FDA product code for PREMIUM - SHELTA Prosthetic Components is NHA.

Related Clinical Trials

NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING

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

K162004PREMIUM Implant Systems SHELTA Implant Systems K172560PREMIUM ONE Implant Systems 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: 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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