510(k) · Cleared

Cleared

Z-LOOK3 Dental Implant System, Model Z3-XXX

K062542510(k) TraditionalCleared Oct 29, 2007425-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

Z-Systems AG · DZE Implant, Endosseous, Root-Form

Cleared on Oct 29, 2007 after a 425-day review. The FDA summary names no predicate by number. 30 later devices descend from it.

Decided: Oct 29, 2007
Review: 425 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

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

This deviceK062542 Z-LOOK3 Dental Implant System, Model Z3-XXXZ-Systems AG · 2007
Descendant · cites it directly · 27 of its ownK093595 Ceraroot Implant SystemOral Iceberg S.L. · 2011
Descendant · cites it directly · 19 of its ownK120793 Z-LOOK3 Evo SLMZ-Systems AG · 2012
Descendant · 2 generations on · 12 of its ownK151328 PURE Ceramic ImplantsStraumann USA · 2016
Descendant · 3 generations on · 8 of its ownK171769 Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
Descendant · 2 generations on · 8 of its ownK132881 Z5CZ-Systems AG · 2014

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2010high 5 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 30 · See all

K093595Ceraroot Implant SystemOral Iceberg S.L. · 2011 · cites it directly27descendants
K120793Z-LOOK3 Evo SLMZ-Systems AG · 2012 · cites it directly19descendants
K151328PURE Ceramic ImplantsStraumann USA · 2016 · 2 generations on12descendants
K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017 · 3 generations on8descendants
K132881Z5CZ-Systems AG · 2014 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K062542	Z-LOOK3 Dental Implant System, Model Z3-XXX	Z-Systems AG	2007	—
+1	K093595	Ceraroot Implant System	Oral Iceberg S.L.	2011	—
+1	K120793	Z-LOOK3 Evo SLM	Z-Systems AG	2012	—
+2	K151328	PURE Ceramic Implants	Straumann USA	2016	—
+3	K171769	Straumann PURE Ceramic Implants	Straumann USA, LLC (On Behalf of Institut Straumann Ag)	2017	—
+2	K132881	Z5C	Z-Systems AG	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2014	3	0
2015	1	0
2016	3	0
2017	1	0
2018	2	0
2019	4	0
2020	5	0
2022	1	0
2023	2	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K062542, 2007–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K093595	Ceraroot Implant System	Oral Iceberg S.L.	2011	27
K120793	Z-LOOK3 Evo SLM	Z-Systems AG	2012	19
K133255	Zeramex T and Zeramex Plus Dental Implant Systems	Dentalpoint AG	2014	3
K131701	Z5MLB, Z5MLC	Z-Systems AG	2013	1
K132585	Zibone Ceramic Dental Implant System	Coho Technology Co., Ltd.	2014	0
K092507	ZIT-Z	Ziterion	2010	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, K093595 (Oral Iceberg S.L., 2011) has gone furthest, with 27 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. 2007, this device’s year, is highlighted.

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?

Z-Look3 Dental Implants are suitable for all indications of endosseous implants in the upper and lower jaw, for the functional and aesthetic oral rehabilitation of edentulous and partially edentulous patients. The Z-Look3 Dental Implants with modifiable abutments are restored with fixed / cemented crowns and bridges. A special indication of the Z-Look3 Dental Implant System is for patients with metal allergies and chronic illnesses due to metal allergies.

Contraindications for the Z-Look3 Dental Implant 0 3.25 mm:

- Restoration of posterior teeth in the upper or lower jaw

- Single-tooth restoration of canines and central incisors in the upper jaw

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062542: Z-LOOK3 Dental Implant System, Model Z3-XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062542

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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