510(k) · Cleared

Cleared

Iti Transversal Screwing System

K943720510(k) TraditionalCleared Mar 24, 1995235-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

The Straumann Co. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 24, 1995 after a 235-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 760 later devices descend from it.

Decided: Mar 24, 1995
Review: 235 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

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

This deviceK943720 Iti Transversal Screwing SystemThe Straumann Co. · 1995
Descendant · cites it directly · 696 of its ownK990342 Synocta ProstheticsStraumann USA · 1999
Descendant · 2 generations on · 575 of its ownK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
Descendant · 2 generations on · 535 of its ownK012757 Iti Dental Implant SystemStraumann USA · 2001
Descendant · 2 generations on · 520 of its ownK022859 Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002
Descendant · 2 generations on · 516 of its ownK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled

Showing 5 of 760 descendants. See all descendants

Descendants cleared per year

1997high 66 (2024) · low 1 (1997)2026

Most influential descendants

Showing 5 of 760 · See all

K990342Synocta ProstheticsStraumann USA · 1999 · cites it directly696descendants
K013798Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001 · 2 generations on575descendants
K012757Iti Dental Implant SystemStraumann USA · 2001 · 2 generations on535descendants
K022859Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002 · 2 generations on520descendants
K020096Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · 2 generations on516descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943720	Iti Transversal Screwing System	The Straumann Co.	1995	—
+1	K990342	Synocta Prosthetics	Straumann USA	1999	—
+2	K013798	Prosthetic Accessories to the Iti Dental Implant System	Institut Straumann AG	2001	—
+2	K012757	Iti Dental Implant System	Straumann USA	2001	—
+2	K022859	Abutment and Prosthetic Accessories to the Iti Dental Implant System	Straumann USA	2002	—
+2	K020096	Esthetic Ease Abutments for the Iti Dental Implant System	Institut Straumann AG	2002	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2001	2	0
2002	3	0
2003	3	0
2004	10	0
2005	7	0
2006	19	0
2007	21	0
2008	18	0
2009	15	0
2010	17	0
2011	22	0
2012	24	0
2013	28	0
2014	34	0
2015	41	0
2016	39	0
2017	37	0
2018	35	0
2019	34	0
2020	54	0
2021	47	0
2022	44	0
2023	59	0
2024	66	0
2025	49	0
2026	28	0

FIG. 1 — Lineage of K943720, 1995–2026Source: 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? (760)

See all 760

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

Number	Device	Applicant	Decided	Descendants
K990342	Synocta Prosthetics	Straumann USA	1999	696
K973353	Bonding Base	Straumann USA	1997	67

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, K990342 (Straumann USA, 1999) has gone furthest, with 696 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/K943720 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943720: Iti Transversal Screwing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943720

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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