510(k) Report

510(k) · Cleared

Cleared

Innovative Implants and Cover Screws

K874590510(k) TraditionalCleared May 11, 1988184-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 May 11, 1988 after a 184-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 494 later devices descend from it.

Decided
May 11, 1988
Review
184 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

494 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2003: 4 descendants cleared1998: 1 descendant cleared2004: 5 descendants cleared1996: 1 descendant cleared2007: 16 descendants cleared2002: 2 descendants cleared2005: 6 descendants cleared2006: 5 descendants cleared2017: 23 descendants cleared2016: 24 descendants cleared2008: 12 descendants cleared2010: 3 descendants cleared2015: 22 descendants cleared2018: 24 descendants cleared2014: 18 descendants cleared2012: 14 descendants cleared2011: 10 descendants cleared2013: 18 descendants cleared2009: 7 descendants cleared2019: 25 descendants cleared2021: 32 descendants cleared2020: 30 descendants cleared2024: 47 descendants cleared2022: 38 descendants cleared2026: 26 descendants cleared2025: 42 descendants cleared2023: 39 descendants cleared1990200020102020
  1. This deviceK874590 Innovative Implants and Cover ScrewsImplant Innovations International, Inc. · 1988
  2. Descendant · cites it directly · 478 of its ownK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
  3. Descendant · 2 generations on · 330 of its ownK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
  4. Descendant · 2 generations on · 320 of its ownK031632 Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003
  5. Descendant · cites it directly · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
  6. Descendant · 2 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004

Showing 5 of 494 descendants. See all descendants

Descendants cleared per year

1996: 11998: 12002: 22003: 42004: 52005: 62006: 52007: 162008: 122009: 72010: 32011: 102012: 142013: 182014: 182015: 222016: 242017: 232018: 242019: 252020: 302021: 322022: 382023: 392024: 472025: 422026: 26
1996high 47 (2024) · low 0 (1997)2026

Most influential descendants

Showing 5 of 494 · See all
  • K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002 · cites it directly478descendants
  • 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 · cites it directly319descendants
  • K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 2 generations on318descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874590Innovative Implants and Cover ScrewsImplant Innovations International, Inc.1988—
+1K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002—
+2K031475Osseotite NT Certain ImplantsImplant Innovations, Inc.2003—
+2K031632Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc.2003—
+1K0306143I Dental ImplantsImplant Innovations, Inc.2003—
+2K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200220
200340
200450
200560
200650
2007160
2008120
200970
201030
2011100
2012140
2013180
2014180
2015220
2016240
2017230
2018240
2019250
2020300
2021320
2022380
2023390
2024470
2025420
2026260
FIG. 1 — Lineage of K874590, 1988–2026Source: 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? (494)

See all 494

9 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
K0306143I Dental ImplantsImplant Innovations, Inc.2003319
K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.2007211
K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc.2007209
K020617Nsi Hexed and Non-Hexed Implant SystemNsi200236
K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432
K042339Neoplant Implant SystemNeobiotech Co., Ltd.20040
K970572Dual Integrator Dental Implant Accessories Parallel Pin, Depth Gage, and Surgical RatchetImplant Integration Systems, Inc.19980
K962610Dual Integrator Dental Implant AccessoriesImplant Integration Systems, Inc.19960

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, K022009 (Implant Innovations, Inc., 2002) has gone furthest, with 478 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

  • K9355443I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
  • 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

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/K874590 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874590: Innovative Implants and Cover Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874590

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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