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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 the device name listed in this FDA 510(k) record. The listed applicant is Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) 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. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K162028.

When did PREMIUM - SHELTA Prosthetic Components receive FDA 510(k) clearance?

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

Who is the listed applicant for PREMIUM - SHELTA Prosthetic Components?

The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Sweden & Martina S.P.A. 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.

K222640Sweden & Martina Surgical TraysK182084Sweden & Martina Surgical Tray (Model ZSHORTY-INT)K180365PRAMA White Implant SystemsK161989PREMIUM Implant Systems SHELTA Implant SystemsK172560PREMIUM ONE Implant SystemsK162004PREMIUM Implant Systems SHELTA Implant Systems

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Related Devices (Code: NHA)

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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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