510(k) · Cleared

Cleared

Surgical Drills

K891615510(k) TraditionalCleared Apr 17, 198928-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 Apr 17, 1989 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 495 later devices descend from it.

Decided: Apr 17, 1989
Review: 28 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

495 later devices descend from it, 2 citing it directly.

This deviceK891615 Surgical DrillsImplant Innovations International, Inc. · 1989
Descendant · cites it directly · 493 of its ownK962014 3I Single Use, Disposable Drills,Taps,Burs, Etc.Implant Innovations, Inc. · 1996
Descendant · 2 generations on · 463 of its ownK022113 3I Dental Implant AccessoriesImplant Innovations, Inc. · 2002
Descendant · 3 generations on · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
Descendant · 4 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
Descendant · 5 generations on · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005

Showing 5 of 495 descendants. See all descendants

Descendants cleared per year

1996high 47 (2024) · low 0 (1997)2026

Most influential descendants

Showing 5 of 495 · See all

K9620143I Single Use, Disposable Drills,Taps,Burs, Etc.Implant Innovations, Inc. · 1996 · cites it directly493descendants
K0221133I Dental Implant AccessoriesImplant Innovations, Inc. · 2002 · 2 generations on463descendants
K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · 3 generations on319descendants
K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 4 generations on318descendants
K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · 5 generations on317descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K891615	Surgical Drills	Implant Innovations International, Inc.	1989	—
+1	K962014	3I Single Use, Disposable Drills,Taps,Burs, Etc.	Implant Innovations, Inc.	1996	—
+2	K022113	3I Dental Implant Accessories	Implant Innovations, Inc.	2002	—
+3	K030614	3I Dental Implants	Implant Innovations, Inc.	2003	—
+4	K041402	Modification to Osseotite NT Certain Implants	Implant Innovations, Inc.	2004	—
+5	K051189	Prevail Dental Implants	Implant Innovations, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
2002	1	0
2003	1	0
2004	3	0
2005	5	0
2006	2	0
2007	11	0
2008	11	0
2009	8	0
2010	2	0
2011	10	0
2012	14	0
2013	20	0
2014	18	0
2015	23	0
2016	26	0
2017	23	0
2018	25	0
2019	27	0
2020	31	0
2021	35	0
2022	40	0
2023	39	0
2024	47	0
2025	43	0
2026	28	0

FIG. 1 — Lineage of K891615, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (495)

See all 495

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

Number	Device	Applicant	Decided	Descendants
K962014	3I Single Use, Disposable Drills,Taps,Burs, Etc.	Implant Innovations, Inc.	1996	493
K962394	Implant Integration Systems Drills and Taps	Implant Integration Systems, Inc.	1996	0

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, K962014 (Implant Innovations, Inc., 1996) has gone furthest, with 493 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

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	—

https://510kreport.com/device/K891615 · printed Nov 5, 2026

Cite this page

510(k) Report. “K891615: Surgical Drills.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K891615

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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