510(k) · Cleared
Recalled · Class II · 2017Endosseous Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Implants, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 16, 2007 as substantially equivalent to K003620 (Nsi, 2001) and 5 other predicates after a 204-day review. Its family tree reaches back 7 generations to 1990. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 16, 2007
- Review
- 204 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 7 generations to K894595 (1990). 51 ancestors in all, the oldest K874590 (1988). 6 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- 2 generations backK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
- 1 generation backK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
- This deviceK071161 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK191054 Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK122664 Zuga Dental Implant SystemZuga Medical, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK110337 Universal Maxillary MolarOco Biomedical · 2012
- Descendant · cites it directly · 0 of its ownK201334 Keystone Dental XL Dental Implant SystemKeystone Dental, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd. · 2019 · cites it directly1descendant
- K122664Zuga Dental Implant SystemZuga Medical, Inc. · 2013 · cites it directly1descendant
- K110337Universal Maxillary MolarOco Biomedical · 2012 · cites it directly1descendant
- K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc. · 2020 · cites it directly0descendants
- K171197Zuga Dental Implant SystemZuga Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −4 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K071161 | Endosseous Dental Implant System | Southern Implants, Inc. | 2007 | — |
| +1 | K191054 | Southern Implants MAX Implant System | Southern Implants (Pty), Ltd. | 2019 | — |
| +1 | K122664 | Zuga Dental Implant System | Zuga Medical, Inc. | 2013 | — |
| +1 | K110337 | Universal Maxillary Molar | Oco Biomedical | 2012 | — |
| +1 | K201334 | Keystone Dental XL Dental Implant System | Keystone Dental, Inc. | 2020 | — |
| +1 | K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | 2018 | — |
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 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (6)
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…able voluntary standards. Southern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium. Predicate Devices: K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System… | 2001 |
| * | K020617 | Nsi Hexed and Non-Hexed Implant SystemSummary page 1…utments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium. Predicate Devices: K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K033171 NSI Hexed and Non-Hexed Implant System… | 2002 |
| * | K033171 | Nsi Hexed and Non-Hexed Implant System and Immediate LoadingSummary page 1…m. Predicate Devices: K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K033171 NSI Hexed and Non-Hexed Implant System K052490 NSI Hexed and Non-Hexed Implant System… | 2004 |
| * | K052490 | Endosseous Dental Implant SystemSummary page 1…tem K020617 NSI Hexed and Non-Hexed Implant System K033171 NSI Hexed and Non-Hexed Implant System K052490 NSI Hexed and Non-Hexed Implant System K053478 NSI Hexed and Non-Hexed Implant System… | 2005 |
| * | K053478 | Endosseous Dental Implant SystemSummary page 1…tem K033171 NSI Hexed and Non-Hexed Implant System K052490 NSI Hexed and Non-Hexed Implant System K053478 NSI Hexed and Non-Hexed Implant System K053353 MegaGen Co. Rescue Implant System Device Description and… | 2006 |
| * | K053353 | Rescue Implant SystemSummary page 1…tem K052490 NSI Hexed and Non-Hexed Implant System K053478 NSI Hexed and Non-Hexed Implant System K053353 MegaGen Co. Rescue Implant System Device Description and Intended Use: The NSI Implant System is intended to be implanted in the… | 2006 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191054 | Southern Implants MAX Implant System | 2019 | 1 |
| K122664 | Zuga Dental Implant System | 2013 | 1 |
| K110337 | Universal Maxillary Molar | 2012 | 1 |
| K201334 | Keystone Dental XL Dental Implant System | 2020 | 0 |
| K171197 | Zuga Dental Implant System | 2018 | 0 |
| K122198 | 6.00MM X 6.00MM Macro External Implant System | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2017 | Class II | Z-0718-2018 | Unknown/Undetermined by firm | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. |
| Jan 23, 2015 | Class II | Z-1265-2015 | Mixed-up of materials/components | Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 51 ancestors have a recall of any class.
- Of its descendants, K191054 (Southern Implants (Pty), Ltd., 2019) has gone furthest, with 1 descendant 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. 2007, 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 NSI MAX Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to morbidity. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It 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/K071161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071161: 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/K071161
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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