510(k) Report

510(k) · Cleared

Cleared

3I Standard Threaded/Self-Tapping Threaded Implants Modification

K935544510(k) TraditionalCleared Mar 13, 1995486-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 International, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 13, 1995 after a 486-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 601 later devices descend from it.

Decided
Mar 13, 1995
Review
486 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

601 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2007: 20 descendants cleared2003: 6 descendants cleared2002: 3 descendants cleared2005: 5 descendants cleared2004: 3 descendants cleared2001: 1 descendant cleared2008: 12 descendants cleared2006: 6 descendants cleared2010: 7 descendants cleared2013: 23 descendants cleared2011: 16 descendants cleared2015: 31 descendants cleared2018: 32 descendants cleared2014: 20 descendants cleared2012: 16 descendants cleared2017: 29 descendants cleared2009: 9 descendants cleared2016: 32 descendants cleared2022: 42 descendants cleared2019: 27 descendants cleared2021: 42 descendants cleared2024: 58 descendants cleared2020: 41 descendants cleared2026: 26 descendants cleared2025: 47 descendants cleared2023: 47 descendants cleared1995200020052010201520202025
  1. This deviceK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
  2. Descendant · cites it directly · 583 of its ownK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
  3. Descendant · cites it directly · 495 of its ownK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
  4. Descendant · cites it directly · 478 of its ownK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
  5. Descendant · cites it directly · 463 of its ownK022113 3I Dental Implant AccessoriesImplant Innovations, Inc. · 2002
  6. Descendant · 2 generations on · 361 of its ownK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007

Showing 5 of 601 descendants. See all descendants

Descendants cleared per year

2001: 12002: 32003: 62004: 32005: 52006: 62007: 202008: 122009: 92010: 72011: 162012: 162013: 232014: 202015: 312016: 322017: 292018: 322019: 272020: 412021: 422022: 422023: 472024: 582025: 472026: 26
2001high 58 (2024) · low 1 (2001)2026

Most influential descendants

Showing 5 of 601 · See all
  • K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002 · cites it directly583descendants
  • K013570Osseotite Dental ImplantsImplant Innovations, Inc. · 2001 · cites it directly495descendants
  • 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
  • K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007 · 2 generations on361descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9355443I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc.1995—
+1K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002—
+1K013570Osseotite Dental ImplantsImplant Innovations, Inc.2001—
+1K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002—
+1K0221133I Dental Implant AccessoriesImplant Innovations, Inc.2002—
+2K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200230
200360
200430
200550
200660
2007200
2008120
200990
201070
2011160
2012160
2013230
2014200
2015310
2016320
2017290
2018320
2019270
2020410
2021420
2022420
2023470
2024580
2025470
2026260
FIG. 1 — Lineage of K935544, 1995–2026Source: 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), 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? (601)

See all 601

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

NumberDeviceApplicantDecidedDescendants
K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002583
K013570Osseotite Dental ImplantsImplant Innovations, Inc.2001495
K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002478
K0221133I Dental Implant AccessoriesImplant Innovations, Inc.2002463
K031475Osseotite NT Certain ImplantsImplant Innovations, Inc.2003330
K031632Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc.2003320
K0306143I Dental ImplantsImplant Innovations, Inc.2003319
K051189Prevail Dental ImplantsImplant Innovations, Inc.2005317
K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312
K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.2007211

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, K014235 (Implant Innovations, Inc., 2002) has gone furthest, with 583 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 Implant Innovations International, Inc.

18 FDA decisions under this applicant name. See the company

  • K932123Implant Innovation Pre-Angled Abutment SystemImplant Innovations International, Inc. · 1994
  • K911655ImplaretteImplant Innovations International, Inc. · 1991
  • K905303Abutment GloImplant Innovations International, Inc. · 1991
  • K911701G-Floss & G-Floss IIImplant Innovations International, Inc. · 1991
  • K891613Overdenture AttachmentImplant Innovations International, Inc. · 19896 recalls

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/K935544 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935544

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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