510(k) · Cleared

Cleared

Iti Dental Implant System Monotype Implant

K002374510(k) TraditionalCleared Nov 1, 200089-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

Straumann USA · DZE Implant, Endosseous, Root-Form

Cleared on Nov 1, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 553 later devices descend from it.

Decided: Nov 1, 2000
Review: 89 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

553 later devices descend from it, 4 citing it directly.

This deviceK002374 Iti Dental Implant System Monotype ImplantStraumann USA · 2000
Descendant · cites it directly · 305 of its ownK013227 Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001 · Recalled
Descendant · cites it directly · 223 of its ownK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
Descendant · 2 generations on · 222 of its ownK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
Descendant · 3 generations on · 211 of its ownK062051 SS SystemOsstem Implant Co., Ltd. · 2006
Descendant · 4 generations on · 202 of its ownK063861 GS SystemOsstem Implant Co., Ltd. · 2007

Showing 5 of 553 descendants. See all descendants

Descendants cleared per year

2001high 54 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 553 · See all

K013227Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001 · cites it directly305descendants
K0118793A Dental Implant SystemOsseco Biosource, Ltd. · 2002 · cites it directly223descendants
K051576Avana Dental Implant SystemOsstem Co., Ltd. · 2005 · 2 generations on222descendants
K062051SS SystemOsstem Implant Co., Ltd. · 2006 · 3 generations on211descendants
K063861GS SystemOsstem Implant Co., Ltd. · 2007 · 4 generations on202descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002374	Iti Dental Implant System Monotype Implant	Straumann USA	2000	—
+1	K013227	Screw Vent Implant; Tapered Screw Vent Implant	Sulzer Dental, Inc.	2001	2
+1	K011879	3A Dental Implant System	Osseco Biosource, Ltd.	2002	—
+2	K051576	Avana Dental Implant System	Osstem Co., Ltd.	2005	—
+3	K062051	SS System	Osstem Implant Co., Ltd.	2006	—
+4	K063861	GS System	Osstem Implant Co., Ltd.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	1	0
2005	3	0
2006	7	0
2007	10	0
2008	18	0
2009	12	0
2010	11	0
2011	16	0
2012	19	0
2013	32	0
2014	25	0
2015	22	0
2016	26	0
2017	24	0
2018	25	0
2019	22	0
2020	42	0
2021	32	0
2022	40	0
2023	54	0
2024	48	0
2025	38	0
2026	23	0

FIG. 1 — Lineage of K002374, 2000–2026Source: 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? (553)

See all 553

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

Number	Device	Applicant	Decided	Descendants
K013227	Screw Vent Implant; Tapered Screw Vent Implant	Sulzer Dental, Inc.	2001	305
K011879	3A Dental Implant System	Osseco Biosource, Ltd.	2002	223
K052369	Exfeel Implant System	Megagen Co., Ltd.	2006	84
K013494	3.75MM and 5.0MM Spline Twist Implant	Sulzer Dental, Inc.	2002	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, K013227 (Sulzer Dental, Inc., 2001) has gone furthest, with 305 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/K002374 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002374: Iti Dental Implant System Monotype Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002374

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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