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Monthly Archives: August 2017

PaxMed Announces the FDA Clearance of DESS Dental Smart Solutions abutments

For immediate release August 8, 2017: PaxMed International, LLC on behalf of Terrats Medical SL of Montcada i Reixac, Spain, announces the clearance of DESS Dental Smart Solutions 510(k). DESS Dental Smart Solutions is a dental implant abutment system that includes seven abutment design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit), and ten abutment connections compatible with […]

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FDA 510(k) user fees increase by as much as 125%

Small Business qualification is more important than ever! Establishment Registration Fee increases by more than a third (to $4,624). In order for a 510(k) submitter to avoid a large increase in the FDA User Fee starting October 1, 2017, it will be very important that a request for Small Business determination (SBD) be submitted well […]

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