510(k) · Cleared
Recalled · Class II · 2026Neodent Implant System - GM Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jjgc Industria E Comercio DE Materiais Dentarios S.A. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 14, 2017 as substantially equivalent to K101945 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2011) and 2 other predicates after a 241-day review. Its family tree reaches back 11 generations to 1990. 30 later devices descend from it. It has been recalled 6 times.
- Decided
- Jul 14, 2017
- Review
- 241 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 11 generations to K894595 (1990). 88 ancestors in all, the oldest K894844 (1990). 30 later devices descend from it, 14 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 2 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 1 generation backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- This deviceK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017
- Descendant · cites it directly · 7 of its ownK200992 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
- Descendant · 2 generations on · 5 of its ownK211921 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
- Descendant · 3 generations on · 4 of its ownK222231 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · Recalled
- Descendant · cites it directly · 3 of its ownK173902 Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- Descendant · cites it directly · 2 of its ownK242686 Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2024 · Recalled
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 8 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 5 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 4 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 3 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 2 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 1 generation backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- This deviceK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · cites it directly7descendants
- K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · 2 generations on5descendants
- K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · 3 generations on4descendants
- K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018 · cites it directly3descendants
- K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2024 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −8 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −5 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −4 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −3 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −2 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −1 | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | Straumann USA | 2013 | — |
| 0 (this device) | K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017 | — |
| +1 | K200992 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
| +2 | K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021 | — |
| +3 | K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2022 | 1 |
| +1 | K173902 | Neodent Implant System – GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018 | — |
| +1 | K242686 | Neodent Implant System | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101945 | Neodent Implant SystemSummary page 4…implant (21 CFR 872.3640) Common Name Root‐form endosseous dental implant Proprietary name Neodent Implant System – GM Line Primary Predicate K101945 ‐ Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA Reference Predicate K15… | 2011 |
| * | K093027 | Straumann RC Temporary AbutmentsSummary page 4…entários SA K153624 ‐ Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA K093027 – Straumann RC Temporary Abutments, Institut Straumann AG K151455 – 3Shape Abutme… | 2010 |
| * | K130808 | Straumann Healing Abutments, Healing Caps, Closure ScrewsSummary page 4…emporary Abutments, Institut Straumann AG K151455 – 3Shape Abutment Designer Software, 3Shape A/S K130808 – Straumann Healing Abutments, Healing Caps and Closure Screws, Institute Straumann AG… | 2013 |
| † | K150182 | Neodent Implant System- CM Drive Implants | 2015 |
| † | K153624 | Neodent Implant System | 2016 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K061804 | Zerion Alpha, ; Zerion Beta | 2006 |
What descends from it? (30)
See all 3014 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200992 | S.I.N. Dental Implant System | 2020 | 7 |
| K173902 | Neodent Implant System – GM Line | 2018 | 3 |
| K242686 | Neodent Implant System | 2024 | 2 |
| K232418 | Single Platform SP1 Implant System | 2023 | 2 |
| K202282 | Neodent Implant System - Zirconia Implant System | 2021 | 2 |
| K180536 | Neodent Implant System – GM Line | 2018 | 2 |
| K231803 | Neodent Implant System - Zirconia Implant System | 2023 | 1 |
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | 2020 | 1 |
| K253922 | Neodent Scannable Healing Abutment | 2026 | 0 |
| K231566 | ICX-Implant System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2026 | Class II | Z-3173-2026 | Under Investigation by firm | 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 | Under Investigation by firm | 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 bone compression or difficulty during… |
| May 1, 2025 | Class II | Z-1863-2025 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 implant is installed, it could result… |
| Oct 2, 2018 | Class II | Z-0455-2019 | Employee error | Laser engraved label does not match with the item in the package |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 88 ancestors have a recall of any class.
- Of its descendants, K200992 (S.I.N. - Sistema DE Implante Nacional S.A., 2020) has gone furthest, with 7 descendants of its own.
- 13 other devices also cite its predicate K101945.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
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…
Read the full statement (205 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163194: Neodent Implant System - GM Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163194
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026