510(k) · Cleared

Cleared

Modification to Iti Dental Implant System

K003271510(k) TraditionalCleared Mar 20, 2001153-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

Institut Straumann AG · DZE Implant, Endosseous, Root-Form

Cleared on Mar 20, 2001 after a 153-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 612 later devices descend from it.

Decided: Mar 20, 2001
Review: 153 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

612 later devices descend from it, 6 citing it directly.

This deviceK003271 Modification to Iti Dental Implant SystemInstitut Straumann AG · 2001
Descendant · cites it directly · 575 of its ownK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
Descendant · cites it directly · 535 of its ownK012757 Iti Dental Implant SystemStraumann USA · 2001
Descendant · 2 generations on · 516 of its ownK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
Descendant · 3 generations on · 514 of its ownK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
Descendant · 2 generations on · 434 of its ownK062129 P.0004 ImplantsInstitut Straumann AG · 2006

Showing 5 of 612 descendants. See all descendants

Descendants cleared per year

2001high 59 (2024) · low 1 (2002)2026

Most influential descendants

Showing 5 of 612 · See all

K013798Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001 · cites it directly575descendants
K012757Iti Dental Implant SystemStraumann USA · 2001 · cites it directly535descendants
K020096Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · 2 generations on516descendants
K033243Iti Synocta Meso AbutmentsStraumann USA · 2003 · 3 generations on514descendants
K062129P.0004 ImplantsInstitut Straumann AG · 2006 · 2 generations on434descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003271	Modification to Iti Dental Implant System	Institut Straumann AG	2001	—
+1	K013798	Prosthetic Accessories to the Iti Dental Implant System	Institut Straumann AG	2001	—
+1	K012757	Iti Dental Implant System	Straumann USA	2001	—
+2	K020096	Esthetic Ease Abutments for the Iti Dental Implant System	Institut Straumann AG	2002	1
+3	K033243	Iti Synocta Meso Abutments	Straumann USA	2003	—
+2	K062129	P.0004 Implants	Institut Straumann AG	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2002	1	0
2003	1	0
2004	4	0
2005	1	0
2006	10	0
2007	14	0
2008	11	0
2009	12	0
2010	15	0
2011	13	0
2012	20	0
2013	24	0
2014	31	0
2015	34	0
2016	31	0
2017	32	0
2018	32	0
2019	27	0
2020	45	0
2021	38	0
2022	39	0
2023	54	0
2024	59	0
2025	37	0
2026	25	0

FIG. 1 — Lineage of K003271, 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

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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? (612)

See all 612

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

Number	Device	Applicant	Decided	Descendants
K013798	Prosthetic Accessories to the Iti Dental Implant System	Institut Straumann AG	2001	575
K012757	Iti Dental Implant System	Straumann USA	2001	535
K033984	Straumann Dental Implant System	Institut Straumann AG	2004	376
K122855	TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants	Straumann USA	2012	123
K082573	Sargon Non-Expandable Dental Implant	Sargon Ent., Inc.	2010	0
K073622	Easy Grip Dental Implant System	T.F.I. System S.R.L	2008	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, K013798 (Institut Straumann AG, 2001) has gone furthest, with 575 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/K003271 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003271: Modification to 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/K003271

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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