510(k) Report

510(k) · Cleared

Cleared

3I Standard Threaded Implant

K954347510(k) TraditionalCleared Apr 1, 1996196-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

Implant Innovations, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Apr 1, 1996 after a 196-day review. The FDA summary names no predicate by number. 1,047 later devices descend from it.

Decided
Apr 1, 1996
Review
196 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

1,047 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2006: 23 descendants cleared2018: 49 descendants cleared2017: 49 descendants cleared2007: 25 descendants cleared2004: 13 descendants cleared2001: 2 descendants cleared2014: 48 descendants cleared2012: 39 descendants cleared2015: 48 descendants cleared2013: 54 descendants cleared2000: 2 descendants cleared2003: 8 descendants cleared2008: 37 descendants cleared2002: 6 descendants cleared2010: 27 descendants cleared2009: 32 descendants cleared2011: 38 descendants cleared2005: 15 descendants cleared2019: 41 descendants cleared2020: 73 descendants cleared2024: 77 descendants cleared2021: 55 descendants cleared2016: 52 descendants cleared2023: 74 descendants cleared2026: 33 descendants cleared2022: 60 descendants cleared2025: 65 descendants cleared1995200020052010201520202025
  1. This deviceK954347 3I Standard Threaded ImplantImplant Innovations, Inc. · 1996
  2. Descendant · cites it directly · 1,043 of its ownK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
  3. Descendant · 2 generations on · 942 of its ownK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
  4. Descendant · 2 generations on · 735 of its ownK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
  5. Descendant · 3 generations on · 689 of its ownK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
  6. Descendant · 4 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004

Showing 5 of 1,047 descendants. See all descendants

Descendants cleared per year

1999: 22000: 22001: 22002: 62003: 82004: 132005: 152006: 232007: 252008: 372009: 322010: 272011: 382012: 392013: 542014: 482015: 482016: 522017: 492018: 492019: 412020: 732021: 552022: 602023: 742024: 772025: 652026: 33
1999high 77 (2024) · low 2 (1999)2026

Most influential descendants

Showing 5 of 1,047 · See all
  • K984104Iti Dental Implant SystemStraumann USA · 1999 · cites it directly1,043descendants
  • K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Nobel Biocare Uas, Inc. · 2000 · 2 generations on942descendants
  • K992937Dental ImplantNobel Biocare Uas, Inc. · 2000 · 2 generations on735descendants
  • K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · 3 generations on689descendants
  • K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · 4 generations on622descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9543473I Standard Threaded ImplantImplant Innovations, Inc.1996—
+1K984104Iti Dental Implant SystemStraumann USA19991
+2K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…Nobel Biocare Uas, Inc.2000—
+2K992937Dental ImplantNobel Biocare Uas, Inc.20001
+3K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc.200227
+4K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200020
200120
200260
200380
2004130
2005150
2006230
2007250
2008370
2009320
2010270
2011380
2012390
2013540
2014480
2015480
2016520
2017490
2018490
2019410
2020730
2021550
2022600
2023740
2024770
2025650
2026330
FIG. 1 — Lineage of K954347, 1996–2026Source: 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), 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?

The FDA summary names no predicate by number.

What descends from it? (1,047)

See all 1,047

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

NumberDeviceApplicantDecidedDescendants
K984104Iti Dental Implant SystemStraumann USA19991,043
K983742Iti Dental Implant SystemInstitut Straumann AG1999510
K053478Endosseous Dental Implant SystemNorthern Implants, LLC200630

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, K984104 (Straumann USA, 1999) has gone furthest, with 1,043 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—

What is it indicated for?

The 3i Implant System is designed for use in dental implant surgery. The 3i Implant System includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants. These implants are surgically inserted into the upper and/or lower jawbones.

A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium or titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.

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

More from Implant Innovations, Inc.

51 FDA decisions under this applicant name. See the company

  • K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental ImplantsImplant Innovations, Inc. · 2007
  • K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 200710 recalls
  • K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 20075 recalls
  • K063403Conical Angled AbutmentImplant Innovations, Inc. · 20075 recalls
  • K061629Certain Prevail Dental ImplantImplant Innovations, Inc. · 2007

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/K954347 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954347: 3I Standard Threaded Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954347

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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