# K193592: Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants - Pathway: 510(k) (Special) - Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A. - Decided: Apr 28, 2020 after 127 days - Product code: DZE (Implant, Endosseous, Root-Form) - Device class: 2 - Regulation: 21 CFR 872.3640 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 15 generations back to K960026 (1996). 150 ancestors in all. No later device cites it as a predicate yet. 0 of 151 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM, Neodent USA, Inc. (2014) Summary page 3. - K150182: Neodent Implant System- CM Drive Implants, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) Summary page 4. - K150199: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) Summary page 5. - K163194: Neodent Implant System - GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2017) Summary page 6. - K180536: Neodent Implant System – GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2018) Summary page 7. ## Indications for use The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. CM Alvim Acqua Implant The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. Facility Acqua Implant The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures. CM Anatomic Abutment, Exact Anatomic, Lateral Anatomic, and Lateral Anatomic Abutments The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Indications for Use for GM Titanium Base abutments: Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. Indications for Use for GM Pro Peek Abutments: The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability. Indications for Use for GM Helix Implants and conventional abutments: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Indications for Use for GM Exact Titanium Block for Medentika Holder: GM Exact Titanium Block for Medentika Holder is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cemented-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center. Indications for Use for GM Exact Titanium Base abutments: Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cemented-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. Indications for Use for Titanium Base C for GM Exact abutments: The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations. All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. Source page: https://510kreport.com/device/K193592 Methodology: https://510kreport.com/methodology