510(k) · Cleared

Cleared

Implant Integration Systems Drills and Taps

K962394510(k) TraditionalCleared Oct 11, 1996113-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 11, 1996 as substantially equivalent to K891615 (Implant Innovations International, Inc., 1989) and 2 other predicates after a 113-day review. Its family tree reaches back 1 generation to 1989.

Decided: Oct 11, 1996
Review: 113 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K891615 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK891615 Surgical DrillsImplant Innovations International, Inc. · 1989
This deviceK962394 Implant Integration Systems Drills and TapsImplant Integration Systems, Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891615	Surgical Drills	Implant Innovations International, Inc.	1989	—
0 (this device)	K962394	Implant Integration Systems Drills and Taps	Implant Integration Systems, Inc.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	1	0

FIG. 1 — Lineage of K962394, 1989–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K891615	Surgical Drills Summary page 1 …plant (K944225). This product is similar in design, composition (titanium nitrade coated stainless steel) and function to the Implant Innovations, Inc. Surgical Drills (K891615), the Impla-Med Corp. Titanium/Stainless Steel Dental Implant Drills (K902158) and the Steri-oss Drills and Taps (K915733). Cor…	Implant Innovations International, Inc.	1989	—
*	K902158	Titanium/Stainless Steel Dental Implant Drill Comp Summary page 1 …ade coated stainless steel) and function to the Implant Innovations, Inc. Surgical Drills (K891615), the Impla-Med Corp. Titanium/Stainless Steel Dental Implant Drills (K902158) and the Steri-oss Drills and Taps (K915733). Cory D /Hanosh, Sales Manager	Impla-Med	1990	—
*	K915733	Steri-Oss Drills and Taps Summary page 1 …the Implant Innovations, Inc. Surgical Drills (K891615), the Impla-Med Corp. Titanium/Stainless Steel Dental Implant Drills (K902158) and the Steri-oss Drills and Taps (K915733). Cory D /Hanosh, Sales Manager	Steri-Oss, Inc.	1992	—

Also cleared against K891615: 1 other device →

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 3 ancestors has a recall.
1 other device also cites its predicate K891615.

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

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

The Implant Integration Systems Surgical Drills are intended to be used in the placement of the “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.

https://510kreport.com/device/K962394 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962394: Implant Integration Systems Drills and Taps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962394

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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