510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Overdenture Attachment

K891613510(k) TraditionalCleared Oct 10, 1989204-day reviewClass II21 CFR 872.3640Recalls 6

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 Oct 10, 1989 after a 204-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 551 later devices descend from it. It has been recalled 6 times.

Decided
Oct 10, 1989
Review
204 days
Class
Class II
Product code
DZE
Recalls
6
Predicates
0

551 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 4 descendants cleared2010: 11 descendants cleared2007: 10 descendants cleared2005: 5 descendants cleared2011: 19 descendants cleared2014: 25 descendants cleared2008: 8 descendants cleared2009: 12 descendants cleared2006: 6 descendants cleared2013: 18 descendants cleared2017: 24 descendants cleared2015: 28 descendants cleared2023: 44 descendants cleared2018: 25 descendants cleared2012: 13 descendants cleared2016: 32 descendants cleared2020: 40 descendants cleared2024: 58 descendants cleared2021: 32 descendants cleared2022: 39 descendants cleared2025: 46 descendants cleared2026: 26 descendants cleared2019: 25 descendants cleared1990200020102020
  1. This deviceK891613 Overdenture AttachmentImplant Innovations International, Inc. · 1989
  2. Descendant · cites it directly · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  4. Descendant · 2 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
  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 551 descendants. See all descendants

Descendants cleared per year

2003: 12004: 42005: 52006: 62007: 102008: 82009: 122010: 112011: 192012: 132013: 182014: 252015: 282016: 322017: 242018: 252019: 252020: 402021: 322022: 392023: 442024: 582025: 462026: 26
2003high 58 (2024) · low 1 (2003)2026

Most influential descendants

Showing 5 of 551 · See all
  • K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · cites it directly476descendants
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 2 generations on441descendants
  • K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on327descendants
  • 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)K891613Overdenture AttachmentImplant Innovations International, Inc.1989—
+1K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
+2K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
+2K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—
+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
200310
200440
200550
200660
2007100
200880
2009120
2010110
2011190
2012130
2013180
2014250
2015280
2016320
2017240
2018250
2019250
2020400
2021320
2022390
2023440
2024580
2025460
2026260
FIG. 1 — Lineage of K891613, 1989–2026Source: 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), 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? (551)

See all 551

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

NumberDeviceApplicantDecidedDescendants
K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.2004476
K0306143I Dental ImplantsImplant Innovations, Inc.2003319
K093975Simpler Toadstool Abutment, Model S19000-S19009Pan Global Implant20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2015Class IIZ-2459-2016PackagingPouches may not have been sealed during packing.
Nov 25, 2015Class IIZ-2461-2016PackagingPouches may not have been sealed during packing.
Nov 25, 2015Class IIZ-2425-2016PackagingPouches may not have been sealed during packing.
Nov 25, 2015Class IIZ-2424-2016PackagingPouches may not have been sealed during packing.
Nov 25, 2015Class IIZ-2460-2016PackagingPouches may not have been sealed during packing.
Nov 25, 2015Class IIZ-2426-2016PackagingPouches may not have been sealed during packing.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K032263 (Implant Innovations, Inc., 2004) has gone furthest, with 476 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/K891613 · printed Nov 5, 2026

Cite this page

510(k) Report. “K891613: Overdenture Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K891613

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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