510(k) · Cleared
ClearedNi2 Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newton Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 11, 2024 as substantially equivalent to K221866 (Newton Implant Systems, Inc., 2024) after a 657-day review. Its family tree reaches back 17 generations to 1990.
- Decided
- Apr 11, 2024
- Review
- 657 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K894595 (1990). 264 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations between
- 3 generations backK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- 2 generations backK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- 1 generation backK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
- This deviceK221847 Ni2 Implant SystemNewton Implant Systems, Inc. · 2024
Show all 17 generations
- Root · 17 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 16 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 15 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 14 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 13 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 12 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 11 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 10 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 9 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 8 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 7 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 6 generations backK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- 5 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 4 generations backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- 3 generations backK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- 2 generations backK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- 1 generation backK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
- This deviceK221847 Ni2 Implant SystemNewton Implant Systems, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −16 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −15 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −14 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −13 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −12 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −11 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −10 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −9 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −8 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −7 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −6 | K123755 | Multi Angled Abutment | Osstem Implant Co., Ltd. | 2013 | — |
| −5 | K132067 | Multi Angled Abutment System | Hiossen, Inc. | 2013 | — |
| −4 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| −3 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| −2 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| −1 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
| 0 (this device) | K221847 | Ni2 Implant System | Newton Implant Systems, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 10 | 0 |
| 1995 | 11 | 0 |
| 1996 | 14 | 0 |
| 1997 | 8 | 0 |
| 1998 | 9 | 0 |
| 1999 | 11 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 17 | 0 |
| 2003 | 16 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 11 | 0 |
| 2007 | 13 | 0 |
| 2008 | 13 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K221866 | S-Plant Dental Implant System Cleared while this submission was under review Summary page 5…osseous, Root-Form • Regulation Number: 21 CFR 872.3640 • Device Class: Class II • Product Code: DZE Predicate Devices Fixture: • S-Plant Dental Implant System (K221866) Reference Device • DIO UF HSA Internal Sub-merged Implant System (K122519) • Noris Medical Dental Implant System -Cortical… | 2024 |
| † | K122519 | Dio UF Hsa Internal Sub-Merged Implant System | 2013 |
| † | K210852 | Noris Medical Dental Implants System - Cortical | 2022 |
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 34 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 27 of the 264 ancestors have a recall of any class.
- 1 other device also cites its predicate K221866.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Ni2 Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller Ni2 dental implants (Ø3.6, 4.0, 5.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good…
Read the full statement (117 words)
The Ni2 Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller Ni2 dental implants (Ø3.6, 4.0, 5.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger Ni2 Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221847: Ni2 Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221847
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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