510(k) Report

510(k) · Cleared

Cleared

Iti Dental Implant System

K983742510(k) TraditionalCleared Mar 15, 1999143-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

Institut Straumann AG · DZE Implant, Endosseous, Root-Form

Cleared on Mar 15, 1999 as substantially equivalent to K894593 (Institut Straumann AG, 1990) and 6 other predicates after a 143-day review. Its family tree reaches back 1 generation to 1990. 510 later devices descend from it.

Decided
Mar 15, 1999
Review
143 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K894593 (1990). 7 ancestors in all. 510 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 4 other ancestors1990: 1 other ancestor2004: 2 descendants cleared2001: 1 descendant cleared2014: 22 descendants cleared2012: 17 descendants cleared2015: 26 descendants cleared2013: 18 descendants cleared2010: 10 descendants cleared2006: 4 descendants cleared2008: 5 descendants cleared2011: 7 descendants cleared2009: 4 descendants cleared2005: 1 descendant cleared2007: 1 descendant cleared2018: 24 descendants cleared2024: 57 descendants cleared2021: 42 descendants cleared2017: 28 descendants cleared2016: 20 descendants cleared2019: 24 descendants cleared2023: 56 descendants cleared2020: 38 descendants cleared2025: 39 descendants cleared2022: 39 descendants cleared2026: 25 descendants clearedK894593 · Bonefit Hollow Cylinder Implants · Institut Straumann AG · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 7 descendants2 generations forward: 31 descendants3 generations forward: 78 descendants4 generations forward: 124 descendants5 generations forward: 112 descendants6 generations forward: 87 descendants7 generations forward: 42 descendants8 generations forward: 18 descendants9 generations forward: 5 descendants10 generations forward: 3 descendants11 generations forward: 3 descendants K894593 · Bonefit Hollow Cylinder Implants · Institut Straumann AG · 19900+5+10
  1. Root · 1 generation backK894593 Bonefit Hollow Cylinder ImplantsInstitut Straumann AG · 1990
  2. This deviceK983742 Iti Dental Implant SystemInstitut Straumann AG · 1999
  3. Descendant · cites it directly · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
  4. Descendant · cites it directly · 346 of its ownK033922 Modification to Iti Dental Implant SystemInstitut Straumann AG · 2004 · Recalled
  5. Descendant · 2 generations on · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
  6. Descendant · 3 generations on · 228 of its ownK083550 Straumann Dental Implant SystemStraumann USA · 2009
  7. Descendant · 3 generations on · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006

Showing 5 of 510 descendants. See all descendants

Descendants cleared per year

2001: 12004: 22005: 12006: 42007: 12008: 52009: 42010: 102011: 72012: 172013: 182014: 222015: 262016: 202017: 282018: 242019: 242020: 382021: 422022: 392023: 562024: 572025: 392026: 25
2001high 57 (2024) · low 0 (2002)2026

Most influential descendants

Showing 5 of 510 · See all
  • K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · cites it directly376descendants
  • K033922Modification to Iti Dental Implant SystemInstitut Straumann AG · 2004 · cites it directly346descendants
  • K053088Slactive ImplantsInstitut Straumann AG · 2006 · 2 generations on295descendants
  • K083550Straumann Dental Implant SystemStraumann USA · 2009 · 3 generations on228descendants
  • K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · 3 generations on228descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894593Bonefit Hollow Cylinder ImplantsInstitut Straumann AG1990—
0 (this device)K983742Iti Dental Implant SystemInstitut Straumann AG1999—
+1K033984Straumann Dental Implant SystemInstitut Straumann AG2004—
+1K033922Modification to Iti Dental Implant SystemInstitut Straumann AG20041
+2K053088Slactive ImplantsInstitut Straumann AG2006—
+3K083550Straumann Dental Implant SystemStraumann USA2009—
+3K060958Straumann Narrow Neck ImplantsStraumann USA2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199640
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200420
200510
200640
200710
200850
200940
2010100
201170
2012170
2013180
2014220
2015260
2016200
2017280
2018240
2019240
2020380
2021420
2022390
2023560
2024570
2025390
2026250
FIG. 1 — Lineage of K983742, 1990–2026Source: 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? (8)

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
*K894593Bonefit Hollow Cylinder Implants
Summary page 1
…Device ~Trade Name: ITI Dental Implant System® Common Name: Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 87 2.3640) hich ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K96…
Institut Straumann AG1990—
*K894595Bonefit R Screw Implants
Summary page 1
…Trade Name: ITI Dental Implant System® Common Name: Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 87 2.3640) hich ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K960417) Th…
Institut Straumann AG1990—
*K971578Endosseous Dental Implant
Summary page 1
…e: ITI Dental Implant System® Common Name: Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 87 2.3640) hich ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K960417) The All-in-…
Straumann USA1997—
*K954512Restore Self Tapping Dental Implant System
Summary page 1
…tion Name: Endosseous Dental Implant (21 CFR 87 2.3640) hich ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K960417) The All-in-One implants are screw and cylinder type dental implants made from C…
Lifecore Biomedical, Inc.1996—
*K960288HA & TPS Restore Self Tapping Dental Implant System
Summary page 1
…: Endosseous Dental Implant (21 CFR 87 2.3640) hich ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K960417) The All-in-One implants are screw and cylinder type dental implants made from CP titani…
Lifecore Biomedical, Inc.1996—
*K9543473I Standard Threaded Implant
Summary page 1
…1 CFR 87 2.3640) hich ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K960417) The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are availabl…
Implant Innovations, Inc.1996—
*K9604173I STND Threaded/Self Tapping Threaded/3I Miniplant Implants/3 I Emergence Prof. Temp.…
Summary page 1
…2.3640) hich ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K960417) The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are available in vari…
Implant Innovations, Inc.1996—
*—Nobel Biocare Branemark implants
Named without a submission number
—

Also cleared against K894593: 3 other devices →

What descends from it? (510)

See all 510

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

NumberDeviceApplicantDecidedDescendants
K033984Straumann Dental Implant SystemInstitut Straumann AG2004376
K033922Modification to Iti Dental Implant SystemInstitut Straumann AG2004346
K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123
K123784Straumann Dental Implant SystemStraumann USA, LLC2013122
K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC2014105
K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC20156
K991822Allfit Implant System, Short Neck, Model Sti RT Length, Allfit Implant System, Long…Dr. Ihde Dental AG Switzerland20010

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 7 ancestors has a recall.
  • Of its descendants, K033984 (Institut Straumann AG, 2004) has gone furthest, with 376 descendants of its own.
  • 3 other devices also cite its predicate K894593.

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?

ITI dental implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures in edentulous or partially edentulous patients.

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 K894593

3 other devices cite the same predicate.

  • K052733Almitech Inc. Dental Implant SystemAlmitech, Inc. · 2005
  • K052490Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
  • K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004

More from Institut Straumann AG

90 FDA decisions under this applicant name. See the company

  • K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG · 2026
  • K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026
  • K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG · 2026
  • K253315Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AG · 2026
  • K250294Straumann® RidgeFit ImplantsInstitut Straumann AG · 2025

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/K983742 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983742: Iti Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983742

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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