510(k) Report

510(k) · Cleared

Cleared

Osseotite Dental Implants

K013570510(k) SpecialCleared Dec 17, 200152-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 Dec 17, 2001 as substantially equivalent to K983347 (Implant Innovations, Inc., 1999) and 2 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1995. 495 later devices descend from it.

Decided
Dec 17, 2001
Review
52 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K935544 (1995). 3 ancestors in all. 495 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 1 other ancestor2002: 2 descendants cleared2003: 6 descendants cleared2007: 15 descendants cleared2008: 11 descendants cleared2005: 5 descendants cleared2006: 6 descendants cleared2004: 3 descendants cleared2010: 5 descendants cleared2016: 24 descendants cleared2022: 38 descendants cleared2009: 9 descendants cleared2018: 25 descendants cleared2017: 23 descendants cleared2012: 14 descendants cleared2011: 10 descendants cleared2014: 18 descendants cleared2019: 24 descendants cleared2015: 22 descendants cleared2013: 18 descendants cleared2021: 33 descendants cleared2024: 47 descendants cleared2023: 39 descendants cleared2020: 30 descendants cleared2026: 26 descendants cleared2025: 42 descendants clearedK935544 · 3I Standard Threaded/Self-Tapping Threaded Implants Modification · Implant Innovations International, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 21 descendants3 generations forward: 66 descendants4 generations forward: 125 descendants5 generations forward: 124 descendants6 generations forward: 74 descendants7 generations forward: 52 descendants8 generations forward: 23 descendants9 generations forward: 3 descendants10 generations forward: 2 descendants11 generations forward: 1 descendant K935544 · 3I Standard Threaded/Self-Tapping Threaded Implants Modification · Implant Innovations International, Inc. · 19950+5+10
  1. Root · 1 generation backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
  2. This deviceK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
  3. Descendant · cites it directly · 478 of its ownK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
  4. Descendant · cites it directly · 463 of its ownK022113 3I Dental Implant AccessoriesImplant Innovations, Inc. · 2002
  5. Descendant · 2 generations on · 330 of its ownK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
  6. Descendant · 2 generations on · 320 of its ownK031632 Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003
  7. Descendant · 2 generations on · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003

Showing 5 of 495 descendants. See all descendants

Descendants cleared per year

2002: 22003: 62004: 32005: 52006: 62007: 152008: 112009: 92010: 52011: 102012: 142013: 182014: 182015: 222016: 242017: 232018: 252019: 242020: 302021: 332022: 382023: 392024: 472025: 422026: 26
2002high 47 (2024) · low 2 (2002)2026

Most influential descendants

Showing 5 of 495 · See all
  • K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002 · cites it directly478descendants
  • K0221133I Dental Implant AccessoriesImplant Innovations, Inc. · 2002 · cites it directly463descendants
  • K031475Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003 · 2 generations on330descendants
  • K031632Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003 · 2 generations on320descendants
  • K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · 2 generations on319descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K9355443I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc.1995—
0 (this device)K013570Osseotite Dental ImplantsImplant Innovations, Inc.2001—
+1K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002—
+1K0221133I Dental Implant AccessoriesImplant Innovations, Inc.2002—
+2K031475Osseotite NT Certain ImplantsImplant Innovations, Inc.2003—
+2K031632Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc.2003—
+2K0306143I Dental ImplantsImplant Innovations, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200360
200430
200550
200660
2007150
2008110
200990
201050
2011100
2012140
2013180
2014180
2015220
2016240
2017230
2018250
2019240
2020300
2021330
2022380
2023390
2024470
2025420
2026260
FIG. 1 — Lineage of K013570, 1995–2026Source: 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? (3)

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
*K983347Osseotite Dental Implants
Summary page 1
…001 OSSEOTITE® Dental Implants Implants, Endosseous Classification: Class III Classification Panels: Dental Regulation Number: 872.3640 e OSSEOTITE® Dental Implants, K983347 (cleared 1/99) e OSSEOTITE® Dental Implant System, K980549 (cleared 4/98) e 3i Standard Threaded/Self-Tapping Threaded Implant,…
Implant Innovations, Inc.1999—
*K980549Osseotite Dental Implant System
Summary page 1
…sification: Class III Classification Panels: Dental Regulation Number: 872.3640 e OSSEOTITE® Dental Implants, K983347 (cleared 1/99) e OSSEOTITE® Dental Implant System, K980549 (cleared 4/98) e 3i Standard Threaded/Self-Tapping Threaded Implant, K935544 (cleared 3/95) 10 Performance Stan…
Implant Innovations, Inc.1998—
*K9355443I Standard Threaded/Self-Tapping Threaded Implants Modification
Summary page 1
…0 e OSSEOTITE® Dental Implants, K983347 (cleared 1/99) e OSSEOTITE® Dental Implant System, K980549 (cleared 4/98) e 3i Standard Threaded/Self-Tapping Threaded Implant, K935544 (cleared 3/95) 10 Performance Standards Device Description Indications for Use Technological Characteristic…
Implant Innovations International, Inc.1995—

Also cleared against K983347: 10 other devices →

What descends from it? (495)

See all 495

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

NumberDeviceApplicantDecidedDescendants
K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002478
K0221133I Dental Implant AccessoriesImplant Innovations, Inc.2002463
K022258B.T.I. Biotechnology Institute, S.L. Dental Implant SystemB.T.I. Biotechnology Institute, Sl.200312
K031055Iti Dental Implant SystemStraumann USA20034

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 3 ancestors has a recall.
  • Of its descendants, K022009 (Implant Innovations, Inc., 2002) has gone furthest, with 478 descendants of its own.
  • 10 other devices also cite its predicate K983347.

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?

3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

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 K983347

10 other devices cite the same predicate.

  • 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
  • K0514613I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
  • K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
  • K031632Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003

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/K013570 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013570: Osseotite Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013570

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026