510(k) · Cleared
ClearedNeodent Implant System - Helix Short Implant System
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 Jun 23, 2023 as substantially equivalent to K163194 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2017) after a 200-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jun 23, 2023
- Review
- 200 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). No later device cites it as a predicate yet.
- 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 deviceK223638 Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2023
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 deviceK223638 Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2023
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) | K223638 | Neodent Implant System - Helix Short Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023 | — |
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 |
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 5…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 R… | 2017 |
| † | K200586 | Straumann TLX Implant System | 2020 |
| † | K123022 | Neodent Implant System | 2013 |
| † | K202942 | Straumann 4 mm Short Implants | 2021 |
| † | K203309 | NUVO CF Implant System | 2021 |
| † | K220251 | Neodent Implant System - GM Narrow Implant System | 2022 |
| † | K182620 | MRI Compatibility for Existing Neodent Implant System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 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.
- 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. 2023, 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 Helix Short Implant: The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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.…
Read the full statement (510 words)
Indications for Use for Helix Short Implant:
The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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 Mini Straight, Angled Abutment and screws:
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 Helix Short Attachment:
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 Helix Short Healing Abutment:
This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).
Indications for Use for Helix Short Cover Screw:
This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The seating of the Cover Screw takes place in the conical region of the implant interface.
Indications for Use for Temporary Abutment for Helix Short 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. Temporary Abutments are indicated to be installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.
Indications for Use for Helix Short Titanium Base:
The Helix Short Implant Titanium Base is a titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223638 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223638: Neodent Implant System - Helix Short Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223638
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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