510(k) · Cleared
ClearedNeodent Implant System - GM Helix Implants 7.0
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 Sep 4, 2020 as substantially equivalent to K163194 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2017) after a 121-day review. Its family tree reaches back 12 generations to 1990. 1 later device descends from it.
- Decided
- Sep 4, 2020
- Review
- 121 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 89 ancestors in all, the oldest K894844 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- 1 generation backK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- This deviceK201225 Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
- Descendant · cites it directly · 0 of its ownK251046 S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 9 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 6 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 5 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 4 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- 1 generation backK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- This deviceK201225 Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
Most influential descendants
Showing 1 of 1 · See all- K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −9 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −6 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −5 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −4 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −3 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −2 | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | Straumann USA | 2013 | — |
| −1 | K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017 | 6 |
| 0 (this device) | K201225 | Neodent Implant System - GM Helix Implants 7.0 | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020 | — |
| +1 | K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025 | — |
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 |
|---|---|---|
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K163194 | Neodent Implant System - GM LineSummary page 4…anel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K163194, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A Refe… | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K101201 | Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model… | 2011 |
| † | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2… | 2020 |
| † | K182620 | MRI Compatibility for Existing Neodent Implant System | 2019 |
| † | K193592 | Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251046 | S.I.N. Dental Implant System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 89 ancestors have a recall of any class.
- Of its descendants, K251046 (S.I.N. Implant System Ltda, 2025) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K163194.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
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 as stated in the FDA summary.
https://510kreport.com/device/K201225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201225: Neodent Implant System - GM Helix Implants 7.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201225
Report an extraction error
Are you the manufacturer?
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