510(k) Report

510(k) · Cleared

Cleared

Nsi Hexed and Non-Hexed Implant System

K020617510(k) TraditionalCleared May 10, 200274-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nsi · DZE Implant, Endosseous, Root-Form

Cleared on May 10, 2002 as substantially equivalent to K003620 (Nsi, 2001) and 8 other predicates after a 74-day review. Its family tree reaches back 1 generation to 1988. 36 later devices descend from it.

Decided
May 10, 2002
Review
74 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
9

Its longest line of descent runs back 1 generation to K874590 (1988). 9 ancestors in all. 36 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor1995: 2 other ancestors1993: 3 other ancestors1990: 1 other ancestor2005: 1 descendant cleared2006: 2 descendants cleared2004: 1 descendant cleared2017: 2 descendants cleared2007: 3 descendants cleared2016: 1 descendant cleared2008: 2 descendants cleared2018: 5 descendants cleared2013: 2 descendants cleared2012: 1 descendant cleared2019: 1 descendant cleared2020: 4 descendants cleared2024: 3 descendants cleared2021: 2 descendants cleared2023: 4 descendants cleared2026: 1 descendant cleared2022: 1 descendant clearedK874590 · Innovative Implants and Cover Screws · Implant Innovations International, Inc. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors 1 generation forward: 9 descendants2 generations forward: 19 descendants3 generations forward: 7 descendants4 generations forward: 1 descendant K874590 · Innovative Implants and Cover Screws · Implant Innovations International, Inc. · 19880
  1. Root · 1 generation backK874590 Innovative Implants and Cover ScrewsImplant Innovations International, Inc. · 1988
  2. This deviceK020617 Nsi Hexed and Non-Hexed Implant SystemNsi · 2002
  3. Descendant · cites it directly · 32 of its ownK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
  4. Descendant · cites it directly · 31 of its ownK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
  5. Descendant · cites it directly · 30 of its ownK053478 Endosseous Dental Implant SystemNorthern Implants, LLC · 2006
  6. Descendant · cites it directly · 24 of its ownK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
  7. Descendant · cites it directly · 21 of its ownK070841 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 22007: 32008: 22012: 12013: 22016: 12017: 22018: 52019: 12020: 42021: 22022: 12023: 42024: 32026: 1
2004high 5 (2018) · low 0 (2009)2026

Most influential descendants

Showing 5 of 36 · See all
  • K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004 · cites it directly32descendants
  • K052490Endosseous Dental Implant SystemNorthern Implants, LLC · 2005 · cites it directly31descendants
  • K053478Endosseous Dental Implant SystemNorthern Implants, LLC · 2006 · cites it directly30descendants
  • K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006 · cites it directly24descendants
  • K070841Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · cites it directly21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K874590Innovative Implants and Cover ScrewsImplant Innovations International, Inc.1988—
0 (this device)K020617Nsi Hexed and Non-Hexed Implant SystemNsi2002—
+1K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC2004—
+1K052490Endosseous Dental Implant SystemNorthern Implants, LLC2005—
+1K053478Endosseous Dental Implant SystemNorthern Implants, LLC2006—
+1K061169Endosseous Dental ImplantNorthern Implants, LLC2006—
+1K070841Endosseous Dental Implant SystemSouthern Implants, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199330
199520
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200620
200730
200820
201210
201320
201610
201720
201850
201910
202040
202120
202210
202340
202430
202610
FIG. 1 — Lineage of K020617, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K003620Nsi Hexed and Non-Hexed Implant System
Summary page 1
…lant System Purpose: The purpose of this supplemental S10(k) is to include additional implants and accessories in the NSI Hexcd and Non-Hexed Endosseous Implant System (K003620) that did not fall within the size range and design shapes identified in our original 510(k) submission for our system. Predicat…
Nsi2001—
*K951111Restore Self Tapping Dental Implant System (3.4MM)
Summary page 1
…within the size range and design shapes identified in our original 510(k) submission for our system. Predicate Devices: K003620 NSI Hexed and Non-[Iexed Implant System K951111 Restore Self-Tapping Dental Implant System K944068 Restore Self-Tapping Dental Implant System K 874590 Innovative Implants and Co…
Lifecore Biomedical, Inc.1995—
*K944068Restore Self Tapping Dental Implant Syst (5, 5.5,6MM)
Summary page 1
…in our original 510(k) submission for our system. Predicate Devices: K003620 NSI Hexed and Non-[Iexed Implant System K951111 Restore Self-Tapping Dental Implant System K944068 Restore Self-Tapping Dental Implant System K 874590 Innovative Implants and Cover Screws K 894594 Bonefit Hollow Screw Implants K…
Lifecore Biomedical, Inc.1995—
*K874590Innovative Implants and Cover Screws
Summary page 1
…Predicate Devices: K003620 NSI Hexed and Non-[Iexed Implant System K951111 Restore Self-Tapping Dental Implant System K944068 Restore Self-Tapping Dental Implant System K 874590 Innovative Implants and Cover Screws K 894594 Bonefit Hollow Screw Implants K925773 Branemark System Gold Cylinders and Screws K0…
Implant Innovations International, Inc.1988—
*K894594Bonefit Hollow Screw Implants
Summary page 1
…[Iexed Implant System K951111 Restore Self-Tapping Dental Implant System K944068 Restore Self-Tapping Dental Implant System K 874590 Innovative Implants and Cover Screws K 894594 Bonefit Hollow Screw Implants K925773 Branemark System Gold Cylinders and Screws K002475 Replace TPS Coated Implant K925769 Brane…
Institut Straumann AG1990—
*K925773Branemark System Gold Cylinders and Screws
Summary page 1
…elf-Tapping Dental Implant System K944068 Restore Self-Tapping Dental Implant System K 874590 Innovative Implants and Cover Screws K 894594 Bonefit Hollow Screw Implants K925773 Branemark System Gold Cylinders and Screws K002475 Replace TPS Coated Implant K925769 Branemark Systems Abutments Complete . K925…
Nobelpharma USA, Inc.1993—
*K002475Replace TPS Coated Implants
Summary page 1
…elf-Tapping Dental Implant System K 874590 Innovative Implants and Cover Screws K 894594 Bonefit Hollow Screw Implants K925773 Branemark System Gold Cylinders and Screws K002475 Replace TPS Coated Implant K925769 Branemark Systems Abutments Complete . K925777 Branemark Systern Etheticone Abutment Complete…
Nobel Biocare Uas, Inc.2000—
*K925769Branemark System Abutments Complete
Summary page 1
…874590 Innovative Implants and Cover Screws K 894594 Bonefit Hollow Screw Implants K925773 Branemark System Gold Cylinders and Screws K002475 Replace TPS Coated Implant K925769 Branemark Systems Abutments Complete . K925777 Branemark Systern Etheticone Abutment Complete Device Description and Intended Us…
Nobelpharma USA, Inc.1993—
*K925777Branemark System Estheticone Abutment Complete
Summary page 1
…894594 Bonefit Hollow Screw Implants K925773 Branemark System Gold Cylinders and Screws K002475 Replace TPS Coated Implant K925769 Branemark Systems Abutments Complete . K925777 Branemark Systern Etheticone Abutment Complete Device Description and Intended Use: The NSI Implant System is intended to be imp…
Nobelpharma USA, Inc.1993—

Also cleared against K003620: 9 other devices →

What descends from it? (36)

See all 36

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432
K052490Endosseous Dental Implant SystemNorthern Implants, LLC200531
K053478Endosseous Dental Implant SystemNorthern Implants, LLC200630
K061169Endosseous Dental ImplantNorthern Implants, LLC200624
K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721
K070905Endosseous Dental Implant SystemSouthern Implants, Inc.200717
K163634External Hex ImplantsSouthern Implants (Pty), Ltd.201713
K071161Endosseous Dental Implant SystemSouthern Implants, Inc.20076
K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.20161

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?

  • None of the 9 ancestors has a recall.
  • Of its descendants, K033171 (Northern Implants, LLC, 2004) has gone furthest, with 32 descendants of its own.
  • 9 other devices also cite its predicate K003620.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K003620

9 other devices cite the same predicate.

  • K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 20171 recall
  • K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016
  • K071161Endosseous Dental Implant SystemSouthern Implants, Inc. · 20072 recalls
  • K070841Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007
  • K070905Endosseous Dental Implant SystemSouthern Implants, Inc. · 20071 recall
  • K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006

More from Nsi

3 FDA decisions under this applicant name. See the company

  • K120581SC Tip CleanerNsi · 2012
  • K003620Nsi Hexed and Non-Hexed Implant SystemNsi · 2001

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K020617 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020617: Nsi Hexed and Non-Hexed 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/K020617

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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