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PaxMed Announces 510(k) Clearance of Neodent Implant System – GM Line

April 20, 2018: PaxMed International LLC announces its 207th 510(k) clearance; the Neodent Implant System – GM Line on behalf of Neodent (JJGC Industria e Comercio de Materiais Dentarios S.A.) of Curitiba Brazil. This clearance expands the Neodent GM line of implants and abutments by adding esthetic GM Exact Co-Cr Abutment for Crown and the GM Equator Attachment. The […]

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PaxMed celebrates its 205th and 206th 510(k) clearances, with a 50-clearance milestone for Dr. Kevin Thomas

PaxMed International announces the FDA 510(k) clearance of Neodent Instrument Kits on behalf of Neodent of Curitiba, Brazil, and 510(k) clearance of NovoGro Putty with a posterolateral spine indication on behalf of OsteoNovus, Inc. of Toledo, Ohio, USA. Neodent Instrument Kits are intended to be used to organize and protect instruments and accessories that are to be sterilized […]

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PaxMed Obtains FDA Clearance for Southern Implants’ Zygomatic System

February 27, 2018: PaxMed proudly announces the FDA clearance of a 510(k) for the Zygomatic System, on behalf of Southern Implants (Pty) Ltd 510(k) of Irene, South Africa. This clearance includes fully-threaded and partially-threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon […]

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Meet with PaxMed as the American Academy of Orthopedic Surgeons in New Orleans

Join us at the 2018 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS), in New Orleans, March 7-10. If you would like to meet with us to explore how PaxMed can help you achieve marketing clearance or approval, please call PaxMed at (858) 792-1235, or send an email message to Carolyn Poirier at […]

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PaxMed Announces the FDA Clearance of Dentium Ti-Base

January 11, 2018: PaxMed International is happy to announce 510(k) clearance of Dentium Ti-Base, on behalf of Dentium Co., Ltd of the Republic of Korea. Dentium Ti-Base abutments are used for support of direct crowns/bridges or for support of CAD/CAM fabricated zirconia copings manufactured by a Dentium validated milling center. The new abutments are compatible with the Dentium […]

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Meet PaxMed March 1-3 at the Academy of Osseointegration 2018 Annual Meeting

Join Founder and President of PaxMed International, Floyd Larson and Senior Regulatory Specialist, Linda Schulz at this year’s Academy of Osseointegration Annual Meeting, March 1-3 at the Los Angeles Convention Center. Digital dentistry is a major topic of discussion among AO attendees, and PaxMed has extensive experience in shepherding digital dentistry products for dental implants through the FDA approval […]

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PaxMed closes out 2017 with its 202nd FDA 510(k) clearance – ORTHOReBIRTH’s ReBOSSIS85 for Posterolateral Spine

December 15, 2017: PaxMed International announces that it closed out a productive 2017 with the FDA 510(k) clearance of K172573 for ReBOSSIS85 resorbable bone void filler, on behalf of Orthorebirth Co., Ltd. of Yokohama, Japan. This submission expands the cleared indications for use of REBOSSIS85 to the posterolateral spine as a bone graft extender. The subject device […]

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PaxMed Obtains its 201st FDA 510(k) Clearance – Biomet 3i TSV BellaTek Encode Healing Abutment

December 13, 2017: PaxMed International announces the beginning of its next hundred FDA 510(k) clearances, with Number 201, on behalf of Biomet 3i of Palm Beach Gardens, Florida, part of the Zimmer Biomet Dental Division. FDA 510(k) clearance of K173374 for TSV BellaTek Encode Healing Abutments brings the proven BellaTek Encode abutment system to the Zimmer […]

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PaxMed Celebrates 200 510(k) Clearances

December 1, 2017 For Immediate Release: PaxMed today is celebrating our 200th FDA 510(k) clearance for our clients. The clearance that marks Number 200 is K170392, for S.I.N. – Sistema de Implante Nacional S.A., of São Paulo, Brazil. The clearance includes four Morse taper product line additions to the S.I.N. Dental Implant System: Unitite Slim, Unitite, Unitite Compact and Strong SW […]

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PaxMed at ASTM Meetings in November

PaxMed International is an active participant in the work of international standards consensus standards bodies, including ASTM, the American Dental Association and ISO. Floyd Larson, PaxMed’s President, chairs ISO and ADA committees and serves as Membership Secretary for ASTM Committee F04 on Medical and Surgical Materials and Devices. Floyd will be in Atlanta, Georgia from November 13-16 […]

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