510(k) · Cleared
ClearedNsi Hexed and Non-Hexed Implant System and Immediate Loading
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northern Implants, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Apr 27, 2004 as substantially equivalent to K003620 (Nsi, 2001) and 8 other predicates after a 210-day review. Its family tree reaches back 5 generations to 1990. 32 later devices descend from it.
- Decided
- Apr 27, 2004
- Review
- 210 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 5 generations to K894595 (1990). 45 ancestors in all, the oldest K874590 (1988). 32 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 2 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 1 generation backK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- This deviceK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
- Descendant · cites it directly · 31 of its ownK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
- Descendant · cites it directly · 24 of its ownK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
- Descendant · cites it directly · 21 of its ownK070841 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK070905 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · Recalled
- Descendant · cites it directly · 14 of its ownK082651 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2008
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K052490Endosseous Dental Implant SystemNorthern Implants, LLC · 2005 · cites it directly31descendants
- K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006 · cites it directly24descendants
- K070841Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · cites it directly21descendants
- K070905Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · cites it directly17descendants
- K082651Endosseous Dental Implant SystemSouthern Implants, Inc. · 2008 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −2 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −1 | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| 0 (this device) | K033171 | Nsi Hexed and Non-Hexed Implant System and Immediate Loading | Northern Implants, LLC | 2004 | — |
| +1 | K052490 | Endosseous Dental Implant System | Northern Implants, LLC | 2005 | — |
| +1 | K061169 | Endosseous Dental Implant | Northern Implants, LLC | 2006 | — |
| +1 | K070841 | Endosseous Dental Implant System | Southern Implants, Inc. | 2007 | — |
| +1 | K070905 | Endosseous Dental Implant System | Southern Implants, Inc. | 2007 | 1 |
| +1 | K082651 | Endosseous Dental Implant System | Southern Implants, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1993 | 10 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003620 | Nsi Hexed and Non-Hexed Implant SystemSummary page 1…xed Implant System Purpose: The purpose of this 510(k) is to include additional implants and accessories in the NSI Hexed and Non-Hexed Endosseous Implant System (K003620) and K(020617 that did not fall within the size range and design shapes identified in our original 510(k) submissions… | 2001 |
| * | K020617 | Nsi Hexed and Non-Hexed Implant SystemSummary page 1…ed usage to include the option for immediate loading. Predicate Devices: K003 620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K874590 Innovative Implants and Cover Screws K97… | 2002 |
| * | K874590 | Innovative Implants and Cover ScrewsSummary page 1…te Devices: K003 620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K874590 Innovative Implants and Cover Screws K970499 Branemark System Zygomaticus Fixture System… | 1988 |
| * | K970499 | Branemark System Zygomaticus Fixture SystemSummary page 1…Implant System K020617 NSI Hexed and Non-Hexed Implant System K874590 Innovative Implants and Cover Screws K970499 Branemark System Zygomaticus Fixture System K894593 Straumann USA Hollow Cylinder implant, l5' angled… | 1997 |
| * | K894593 | Bonefit Hollow Cylinder ImplantsSummary page 1…nt System K874590 Innovative Implants and Cover Screws K970499 Branemark System Zygomaticus Fixture System K894593 Straumann USA Hollow Cylinder implant, l5' angled K022562 Nobel Biocare Various Branemark System Dental Impl… | 1990 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…K970499 Branemark System Zygomaticus Fixture System K894593 Straumann USA Hollow Cylinder implant, l5' angled K022562 Nobel Biocare Various Branemark System Dental Implant Products K0241 11 and K012965 Astra Dental Implants… | 2002 |
| * | K024111 | Astra Tech Implants-Dental System Fixture OsseospeedSummary page 1…894593 Straumann USA Hollow Cylinder implant, l5' angled K022562 Nobel Biocare Various Branemark System Dental Implant Products K0241 11 and K012965 Astra Dental Implants K03 0007 ITI Straumann Dental Implant System K024004… | 2003 |
| Kept off the family tree | K012965 | Astra Dental Implants Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ann USA Hollow Cylinder implant, l5' angled K022562 Nobel Biocare Various Branemark System Dental Implant Products K0241 11 and K012965 Astra Dental Implants K03 0007 ITI Straumann Dental Implant System K024004 Friadent XiV… | |
| * | K030007 | Iti Dental Implant SystemSummary page 1…K022562 Nobel Biocare Various Branemark System Dental Implant Products K0241 11 and K012965 Astra Dental Implants K03 0007 ITI Straumann Dental Implant System K024004 Friadent XiVE Transgingival Dental Implant System Device Descri… | 2003 |
| * | K024004 | Xive Transgingival Dental Implant SystemSummary page 1…l Implant Products K0241 11 and K012965 Astra Dental Implants K03 0007 ITI Straumann Dental Implant System K024004 Friadent XiVE Transgingival Dental Implant System Device Description and Intended Use: The NSI Implant System is intended for im… | 2003 |
What descends from it? (32)
See all 326 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K052490 (Northern Implants, LLC, 2005) has gone furthest, with 31 descendants of its own.
- 9 other devices also cite its predicate K003620.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033171: Nsi Hexed and Non-Hexed Implant System and Immediate Loading.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033171
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