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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 CM. The Unitite product line is provided with an acid-etched surface which has a nanocrystalline HA coating developed by Promimic AB, of Göteborg, Sweden.

Other recent 510(k) clearances that led to this milestone include K163634 for Southern Implants (Pty) Ltd. of Irene, South Africa, with four external hex implant/abutment product lines: External Hex Tapered Implants, External Hex Tapered Internal Drive Implants, External Hex Cylindrical Internal Drive Implants, and External Hex Co-Axis Tapered Implants.

An additional recent PaxMed FDA 510(k) clearance for S.I.N. – Sistema de Implante Nacional S.A. is K170398, for six external and internal hex implant product lines: Revolution, Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn and Strong SW HI.