ClearanceBrief
510(k) K163194 ยท DZE Implant, Endosseous, Root-Form

Neodent Implant System - GM Line

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A., Curitiba, BR
DecisionSubstantially Equivalent, Jul 14, 2017
ReceivedNov 15, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K163194

DateFirm and productCodeLinked 510(k)
Sep 15, 2026Straumann USA LLC
GM Helix Implant, REF: 109.984;
Open, Classified		 DZENone listed
Aug 10, 2026Straumann USA LLC
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Open, Classified		 NHANone listed
May 28, 2025Straumann USA LLC
GM Helix Acqua Implant, Article Number: 140.984
Open, Classified		 DZENone listed
May 28, 2025Straumann USA LLC
GM Helix Acqua Implant, Article Number: 140.985
Open, Classified		 DZENone listed
Oct 11, 2021Jjgc Industria E Comercio De Materials Dentarios Sa
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Terminated		 DZENone listed
Oct 2, 2018Straumann Manufacturing, Inc.
Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a
Terminated		 DZENone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.