510(k) · Cleared

Cleared

Iti Dental Implant System

K010291510(k) TraditionalCleared May 10, 200199-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 May 10, 2001 after a 99-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 482 later devices descend from it.

Decided: May 10, 2001
Review: 99 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

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

This deviceK010291 Iti Dental Implant SystemStraumann USA · 2001
Descendant · cites it directly · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
Descendant · 2 generations on · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
Descendant · 3 generations on · 228 of its ownK083550 Straumann Dental Implant SystemStraumann USA · 2009
Descendant · cites it directly · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
Descendant · 2 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011

Showing 5 of 482 descendants. See all descendants

Descendants cleared per year

2004high 55 (2024) · low 1 (2004)2026

Most influential descendants

Showing 5 of 482 · See all

K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · cites it directly376descendants
K053088Slactive ImplantsInstitut Straumann AG · 2006 · 2 generations on295descendants
K083550Straumann Dental Implant SystemStraumann USA · 2009 · 3 generations on228descendants
K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · cites it directly228descendants
K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 2 generations on222descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010291	Iti Dental Implant System	Straumann USA	2001	—
+1	K033984	Straumann Dental Implant System	Institut Straumann AG	2004	—
+2	K053088	Slactive Implants	Institut Straumann AG	2006	—
+3	K083550	Straumann Dental Implant System	Straumann USA	2009	—
+1	K060958	Straumann Narrow Neck Implants	Straumann USA	2006	—
+2	K111357	Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System	Straumann USA	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	4	0
2007	1	0
2008	5	0
2009	3	0
2010	9	0
2011	6	0
2012	17	0
2013	18	0
2014	19	0
2015	23	0
2016	19	0
2017	26	0
2018	24	0
2019	24	0
2020	35	0
2021	39	0
2022	38	0
2023	54	0
2024	55	0
2025	36	0
2026	25	0

FIG. 1 — Lineage of K010291, 2001–2026Source: 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (482)

See all 482

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

Number	Device	Applicant	Decided	Descendants
K033984	Straumann Dental Implant System	Institut Straumann AG	2004	376
K060958	Straumann Narrow Neck Implants	Straumann USA	2006	228
K061176	Straumann Dental Implants	Institut Straumann AG	2006	148

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, K033984 (Institut Straumann AG, 2004) has gone furthest, with 376 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/K010291 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010291: Iti Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010291

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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