510(k) Report

510(k) · Cleared

Cleared

Dual Integrator Dental Implant Accessories

K962610510(k) TraditionalCleared Oct 18, 1996107-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 Integration Systems, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Oct 18, 1996 as substantially equivalent to K904709 (Minimatic Implant Technology, 1991) and 3 other predicates after a 107-day review. Its family tree reaches back 1 generation to 1988.

Decided
Oct 18, 1996
Review
107 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K874590 (1988). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 2 other ancestors1990: 1 other ancestorK874590 · Innovative Implants and Cover Screws · Implant Innovations International, Inc. · 19881986198819901992199419961998
Other ancestors, by generation 1 generation back: 3 other ancestors K874590 · Innovative Implants and Cover Screws · Implant Innovations International, Inc. · 19880
  1. Root · 1 generation backK874590 Innovative Implants and Cover ScrewsImplant Innovations International, Inc. · 1988
  2. This deviceK962610 Dual Integrator Dental Implant AccessoriesImplant Integration Systems, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K874590Innovative Implants and Cover ScrewsImplant Innovations International, Inc.1988—
0 (this device)K962610Dual Integrator Dental Implant AccessoriesImplant Integration Systems, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199120
FIG. 1 — Lineage of K962610, 1988–1996Source: 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), 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? (4)

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
*K904709BC 1213 Healing Screw
Summary page 1
…5). This product is similar in design, composition (Pure-Ti CP-3, Ti Alloy CP-4, and stainless steel) and function to the Minimatic Implant Tech. BC 1213 Healing Screw (K904709), the Dental Imaging Assoc. Dia Healing Cap (K902434), the Minimatic Implant Tech. HS-1113 Healing Screw (K903062), the Implant I…
Minimatic Implant Technology1991—
*K902434Dia Healing Cap
Summary page 1
…Pure-Ti CP-3, Ti Alloy CP-4, and stainless steel) and function to the Minimatic Implant Tech. BC 1213 Healing Screw (K904709), the Dental Imaging Assoc. Dia Healing Cap (K902434), the Minimatic Implant Tech. HS-1113 Healing Screw (K903062), the Implant Innovations Int. Innovative Implants and Cover Screws…
Dental Imaging Assoc., Inc.1991—
*K903062HS-1113 Healing Screw - Rev. a
Summary page 1
…n to the Minimatic Implant Tech. BC 1213 Healing Screw (K904709), the Dental Imaging Assoc. Dia Healing Cap (K902434), the Minimatic Implant Tech. HS-1113 Healing Screw (K903062), the Implant Innovations Int. Innovative Implants and Cover Screws (K874590), as well as, healing screws/caps and tools from an…
Minimatic Implant Technology1990—
*K874590Innovative Implants and Cover Screws
Summary page 1
…Imaging Assoc. Dia Healing Cap (K902434), the Minimatic Implant Tech. HS-1113 Healing Screw (K903062), the Implant Innovations Int. Innovative Implants and Cover Screws (K874590), as well as, healing screws/caps and tools from any other implant system. Cory D. fign))sh, Sales Manager 7”/- Cié> Date
Implant Innovations International, Inc.1988—

What descends from it?

No later submission names this one as a predicate yet.

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 4 ancestors has a recall.

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?

The “Dual Integrator” Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems “Dual Integrator” Dental Implant (K944225).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Implant Integration Systems, Inc.

4 FDA decisions under this applicant name. See the company

  • K970572Dual Integrator Dental Implant Accessories Parallel Pin, Depth Gage, and Surgical RatchetImplant Integration Systems, Inc. · 1998
  • K962394Implant Integration Systems Drills and TapsImplant Integration Systems, Inc. · 1996
  • K944225Dual Integrator Dental ImplantImplant Integration Systems, Inc. · 1995

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/K962610 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962610: Dual Integrator Dental Implant Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962610

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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