510(k) · Cleared

Recalled · 2003

Iti Dental Implant System

K984104510(k) TraditionalCleared May 13, 1999177-day reviewClass II21 CFR 872.3640Recalls 1

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 13, 1999 as substantially equivalent to K894595 (Institut Straumann AG, 1990) and 7 other predicates after a 177-day review. Its family tree reaches back 1 generation to 1990. 1,043 later devices descend from it. It has been recalled once.

Decided: May 13, 1999
Review: 177 days
Class: Class II
Product code: DZE
Recalls: 1
Predicates: 8

Its longest line of descent runs back 1 generation to K894595 (1990). 8 ancestors in all. 1,043 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 1 generation backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
This deviceK984104 Iti Dental Implant SystemStraumann USA · 1999
Descendant · cites it directly · 942 of its ownK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
Descendant · cites it directly · 735 of its ownK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
Descendant · 2 generations on · 689 of its ownK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
Descendant · 3 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
Descendant · cites it directly · 570 of its ownK030007 Iti Dental Implant SystemStraumann USA · 2003

Showing 5 of 1,043 descendants. See all descendants

Descendants cleared per year

2000high 77 (2024) · low 1 (2001)2026

Most influential descendants

Showing 5 of 1,043 · See all

K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Nobel Biocare Uas, Inc. · 2000 · cites it directly942descendants
K992937Dental ImplantNobel Biocare Uas, Inc. · 2000 · cites it directly735descendants
K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · 2 generations on689descendants
K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · 3 generations on622descendants
K030007Iti Dental Implant SystemStraumann USA · 2003 · cites it directly570descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
0 (this device)	K984104	Iti Dental Implant System	Straumann USA	1999	—
+1	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…	Nobel Biocare Uas, Inc.	2000	—
+1	K992937	Dental Implant	Nobel Biocare Uas, Inc.	2000	1
+2	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	27
+3	K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	—
+1	K030007	Iti Dental Implant System	Straumann USA	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	2	0
1996	2	0
1997	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0
2001	1	0
2002	6	0
2003	8	0
2004	13	0
2005	15	0
2006	22	0
2007	25	0
2008	37	0
2009	32	0
2010	27	0
2011	38	0
2012	39	0
2013	54	0
2014	48	0
2015	48	0
2016	52	0
2017	49	0
2018	49	0
2019	41	0
2020	73	0
2021	55	0
2022	60	0
2023	74	0
2024	77	0
2025	65	0
2026	33	0

FIG. 1 — Lineage of K984104, 1990–2026Source: 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

Get a 510(k) Report

What was it cleared against? (8)

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
*	K894595	Bonefit R Screw Implants Summary page 1 …Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Legally Mirkted Devi hich Equival is Claimed (Predi Devices) . . ITI Dental Iriplants (K894595, K971578) Nobel Bioca ‘e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implame…	Institut Straumann AG	1990	—
*	K971578	Endosseous Dental Implant Summary page 1 …mplant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Legally Mirkted Devi hich Equival is Claimed (Predi Devices) . . ITI Dental Iriplants (K894595, K971578) Nobel Bioca ‘e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implamed Implant…	Straumann USA	1997	—
*	K925765	Branemark System Standard 3.75MM Fixture Summary page 1 …Implant (21 CFR 872.3640) Legally Mirkted Devi hich Equival is Claimed (Predi Devices) . . ITI Dental Iriplants (K894595, K971578) Nobel Bioca ‘e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implamed Implants (K981516) SARGON Dental Implants (K930071)…	Nobelpharma USA, Inc.	1993	—
*	K934825	Branemark System Summary page 1 …(21 CFR 872.3640) Legally Mirkted Devi hich Equival is Claimed (Predi Devices) . . ITI Dental Iriplants (K894595, K971578) Nobel Bioca ‘e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implamed Implants (K981516) SARGON Dental Implants (K930071) Descrip…	Nobelpharma USA, Inc.	1994	—
*	K954347	3I Standard Threaded Implant Summary page 1 …hich Equival is Claimed (Predi Devices) . . ITI Dental Iriplants (K894595, K971578) Nobel Bioca ‘e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implamed Implants (K981516) SARGON Dental Implants (K930071) Description._of the Device The All-in-O1e imp…	Implant Innovations, Inc.	1996	—
*	K960417	3I STND Threaded/Self Tapping Threaded/3I Miniplant Implants/3 I Emergence Prof. Temp.… Summary page 1 …ival is Claimed (Predi Devices) . . ITI Dental Iriplants (K894595, K971578) Nobel Bioca ‘e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implamed Implants (K981516) SARGON Dental Implants (K930071) Description._of the Device The All-in-O1e implants are…	Implant Innovations, Inc.	1996	—
*	K981516	Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA… Summary page 1 …TI Dental Iriplants (K894595, K971578) Nobel Bioca ‘e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implamed Implants (K981516) SARGON Dental Implants (K930071) Description._of the Device The All-in-O1e implants are screw type dental implants made from…	Sterngold/Implamed	1998	—
*	K930071	Sargon Cylindro-Blade Implant Summary page 1 …578) Nobel Bioca ‘e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implamed Implants (K981516) SARGON Dental Implants (K930071) Description._of the Device The All-in-O1e implants are screw type dental implants made from CP titanium, Grade 4. They are ava…	Sargon Ent., Inc.	1994	—

Also cleared against K894595: 6 other devices →

What descends from it? (1,043)

See all 1,043

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

Number	Device	Applicant	Decided	Descendants
K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)	Nobel Biocare Uas, Inc.	2000	942
K992937	Dental Implant	Nobel Biocare Uas, Inc.	2000	735
K030007	Iti Dental Implant System	Straumann USA	2003	570
K033984	Straumann Dental Implant System	Institut Straumann AG	2004	376
K030614	3I Dental Implants	Implant Innovations, Inc.	2003	319
K013227	Screw Vent Implant; Tapered Screw Vent Implant	Sulzer Dental, Inc.	2001	305
K012681	Ankylos	Dentsply Ceramco	2003	7
K021322	Endossous Implants	Intra-Lock International	2002	6
K073622	Easy Grip Dental Implant System	T.F.I. System S.R.L	2008	0
K013494	3.75MM and 5.0MM Spline Twist Implant	Sulzer Dental, Inc.	2002	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 25, 2003	Not classified	Z-0871-03	Other	Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 8 ancestors has a recall.
Of its descendants, K993595 (Nobel Biocare Uas, Inc., 2000) has gone furthest, with 942 descendants of its own.
6 other devices also cite its predicate K894595.

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?

ITI One Part octa implants are intended for surgical placement in the maxillary; and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

ITI one-part octa implants are for use in edentulous jaws in conjunction with bar-borne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.

ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

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/K984104 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984104: 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/K984104

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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