510(k) · Cleared
ClearedEndosseous Dental Implant System
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 5, 2006 as substantially equivalent to K003620 (Nsi, 2001) and 2 other predicates after a 112-day review. Its family tree reaches back 2 generations to 1988. 30 later devices descend from it.
- Decided
- Apr 5, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K874590 (1988). 11 ancestors in all. 30 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK874590 Innovative Implants and Cover ScrewsImplant Innovations International, Inc. · 1988
- 1 generation backK020617 Nsi Hexed and Non-Hexed Implant SystemNsi · 2002
- This deviceK053478 Endosseous Dental Implant SystemNorthern Implants, LLC · 2006
- 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 · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · cites it directly · 7 of its ownK163060 Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- 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
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · cites it directly13descendants
- K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874590 | Innovative Implants and Cover Screws | Implant Innovations International, Inc. | 1988 | — |
| −1 | K020617 | Nsi Hexed and Non-Hexed Implant System | Nsi | 2002 | — |
| 0 (this device) | K053478 | Endosseous Dental Implant System | Northern Implants, LLC | 2006 | — |
| +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 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +1 | K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants (Pty), Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 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? (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 |
|---|---|---|---|
| * | K003620 | Nsi Hexed and Non-Hexed Implant SystemSummary page 1…voluntary standards. Northern Implant's screw-type implants and abutments are manufactured from ASTM E67-95 Grade III or Grade IV Titanium. Predicate Devices: K(003620 NSI Hexed and Non-Hexed Implant System K(020617 NSI Hlexed and Non-flexed Implant System K(954347 Implant Innova… | 2001 |
| * | K020617 | Nsi Hexed and Non-Hexed Implant SystemSummary page 1…nts and abutments are manufactured from ASTM E67-95 Grade III or Grade IV Titanium. Predicate Devices: K(003620 NSI Hexed and Non-Hexed Implant System K(020617 NSI Hlexed and Non-flexed Implant System K(954347 Implant Innovations 3.25mm microminiplant Device Description and Inte… | 2002 |
| * | K954347 | 3I Standard Threaded ImplantSummary page 1…Grade III or Grade IV Titanium. Predicate Devices: K(003620 NSI Hexed and Non-Hexed Implant System K(020617 NSI Hlexed and Non-flexed Implant System K(954347 Implant Innovations 3.25mm microminiplant Device Description and Intended Use: The NSI Implant System is intended to be implante… | 1996 |
What descends from it? (30)
See all 308 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061169 | Endosseous Dental Implant | 2006 | 24 |
| K070841 | Endosseous Dental Implant System | 2007 | 21 |
| K070905 | Endosseous Dental Implant System | 2007 | 17 |
| K163634 | External Hex Implants | 2017 | 13 |
| K163060 | Deep Conical (DC) Implants and Accessories | 2017 | 7 |
| K071161 | Endosseous Dental Implant System | 2007 | 6 |
| K180465 | Provata Implant System | 2018 | 2 |
| K173343 | Zygomatic Implant System | 2018 | 2 |
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 18 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K061169 (Northern Implants, LLC, 2006) has gone furthest, with 24 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 loading on single and splinted multiple unit restorations 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/K053478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053478: Endosseous Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053478
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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