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FDA 510(k)

SWISSPLANT DENTAL IMPLANT SYSTEM

K-Number: K081396 · 2009-01-14

ApplicantImplant Direct, LLC
Decision Date2009-01-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SWISSPLANT DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct, LLC. It received FDA 510(k) clearance on 2009-01-14 under 510(k) number K081396. 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 SWISSPLANT DENTAL IMPLANT SYSTEM?

SWISSPLANT DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-14. The listed applicant is Implant Direct, LLC. The 510(k) number is K081396.

When did SWISSPLANT DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

SWISSPLANT DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2009-01-14, under 510(k) number K081396.

Who is the listed applicant for SWISSPLANT DENTAL IMPLANT SYSTEM?

The FDA 510(k) record lists Implant Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWISSPLANT DENTAL IMPLANT SYSTEM?

The FDA product code for SWISSPLANT DENTAL IMPLANT SYSTEM is NHA.

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Other records listing Implant Direct, LLC 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.

K090234SPECTRA SYSTEM DENTAL IMPLANTS 2008K081101SPECTRA-SYSTEM ABUTMENTS 2008K080633SCREWINDIRECT DENTAL IMPLANTSK080713REACTIVE DENTAL IMPLANT SYSTEMK073161REPLUS DENTAL IMPLANTS (HA)K073049SCREWPLUS DENTAL IMPLANTS (HA)

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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.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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.

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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