510(k) Report

510(k) · Cleared

Cleared

Nsi Hexed and Non-Hexed Implant System

K003620510(k) TraditionalCleared Sep 19, 2001301-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 Sep 19, 2001 after a 301-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.

Decided
Sep 19, 2001
Review
301 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

37 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 2 descendants cleared2004: 1 descendant cleared2017: 2 descendants cleared2007: 3 descendants cleared2016: 1 descendant cleared2002: 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 cleared200020052010201520202025
  1. This deviceK003620 Nsi Hexed and Non-Hexed Implant SystemNsi · 2001
  2. Descendant · cites it directly · 36 of its ownK020617 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

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12005: 12006: 22007: 32008: 22012: 12013: 22016: 12017: 22018: 52019: 12020: 42021: 22022: 12023: 42024: 32026: 1
2002high 5 (2018) · low 0 (2003)2026

Most influential descendants

Showing 5 of 37 · See all
  • K020617Nsi Hexed and Non-Hexed Implant SystemNsi · 2002 · cites it directly36descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003620Nsi Hexed and Non-Hexed Implant SystemNsi2001—
+1K020617Nsi 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200510
200620
200730
200820
201210
201320
201610
201720
201850
201910
202040
202120
202210
202340
202430
202610
FIG. 1 — Lineage of K003620, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K020617Nsi Hexed and Non-Hexed Implant SystemNsi200236
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?

  • Of its descendants, K020617 (Nsi, 2002) has gone furthest, with 36 descendants of its own.

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—

More from Nsi

3 FDA decisions under this applicant name. See the company

  • K120581SC Tip CleanerNsi · 2012
  • K020617Nsi Hexed and Non-Hexed Implant SystemNsi · 2002

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/K003620 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003620: Nsi Hexed and Non-Hexed Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003620

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026