Leaders in Regulatory Affairs for the Medical Device Industry

Monthly Archives: January 2018

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 […]

Read More

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 […]

Read More

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 […]

Read More

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 […]

Read More