# K163194: Neodent Implant System - GM Line

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Jul 14, 2017 after 241 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894595 (1990). 88 ancestors in all.
30 later devices descend from it; 14 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 4.
- K093027: Straumann RC Temporary Abutments, Straumann USA (2010) Summary page 4.
- K130808: Straumann Healing Abutments, Healing Caps, Closure Screws, Straumann USA (2013) Summary page 4.

## Most influential descendants
- K200992: S.I.N. Dental Implant System (2020), 7 descendants of its own
- K211921: S.I.N. Dental Implant System (2021), 5 descendants of its own
- K222231: S.I.N. Dental Implant System (2022), 4 descendants of its own
- K173902: Neodent Implant System – GM Line (2018), 3 descendants of its own
- K242686: Neodent Implant System (2024), 2 descendants of its own

## Recalls of this device
- Aug 12, 2026 · Class II · Z-3173-2026: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Jul 13, 2026 · Class II · Z-2929-2026: There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bon
- May 1, 2025 · Class II · Z-1863-2025: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- May 1, 2025 · Class II · Z-1862-2025: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- Oct 11, 2021 · Class II · Z-0203-2022: 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect 
- Oct 2, 2018 · Class II · Z-0455-2019: Laser engraved label does not match with the item in the package

## Indications for use
Indications for Use for GM 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 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.

Source page: https://510kreport.com/device/K163194
Methodology: https://510kreport.com/methodology