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FDA 510(k)

PREMIUM Implant Systems SHELTA Implant Systems

K-Number: K162004 · 2016-12-05

ApplicantSweden & Martina S.P.A.
Decision Date2016-12-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIUM Implant Systems SHELTA Implant Systems 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 2016-12-05 under 510(k) number K162004. 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 2016-12-05. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K162004.

When did PREMIUM Implant Systems SHELTA Implant Systems receive FDA 510(k) clearance?

PREMIUM Implant Systems SHELTA Implant Systems received FDA 510(k) clearance on 2016-12-05, under 510(k) number K162004.

Who is the listed applicant for PREMIUM Implant Systems SHELTA Implant Systems?

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 Implant Systems SHELTA Implant Systems?

The FDA product code for PREMIUM Implant Systems SHELTA Implant Systems 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 SystemsK162028PREMIUM - SHELTA Prosthetic Components

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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.

K261147Neodent 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, LLCK260564DESS Dental Smart SolutionsTerrats Medical SL

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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