510(k) · Cleared

Cleared

Z-LOOK3 Evo SLM

K120793510(k) TraditionalCleared Dec 21, 2012281-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 Dec 21, 2012 as substantially equivalent to K062542 (Z-Systems AG, 2007) and 4 other predicates after a 281-day review. Its family tree reaches back 3 generations to 2002. 19 later devices descend from it.

Decided: Dec 21, 2012
Review: 281 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K022562 (2002). 7 ancestors in all. 19 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 3 generations backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
2 generations backK061971 Zirconia ImplantNobel Biocare AB · 2007
1 generation backK093595 Ceraroot Implant SystemOral Iceberg S.L. · 2011
This deviceK120793 Z-LOOK3 Evo SLMZ-Systems AG · 2012
Descendant · cites it directly · 12 of its ownK151328 PURE Ceramic ImplantsStraumann USA · 2016
Descendant · 2 generations on · 8 of its ownK171769 Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
Descendant · cites it directly · 8 of its ownK132881 Z5CZ-Systems AG · 2014
Descendant · 3 generations on · 6 of its ownK180477 Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019
Descendant · 2 generations on · 4 of its ownK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2013high 5 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 19 · See all

K151328PURE Ceramic ImplantsStraumann USA · 2016 · cites it directly12descendants
K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017 · 2 generations on8descendants
K132881Z5CZ-Systems AG · 2014 · cites it directly8descendants
K180477Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019 · 3 generations on6descendants
K172668W Zirconia ImplantsTav Medical, Ltd. · 2018 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K022562	Various Branemark System Implants-Immediate Function Indication	Nobel Biocare AB	2002	—
−2	K061971	Zirconia Implant	Nobel Biocare AB	2007	—
−1	K093595	Ceraroot Implant System	Oral Iceberg S.L.	2011	—
0 (this device)	K120793	Z-LOOK3 Evo SLM	Z-Systems AG	2012	—
+1	K151328	PURE Ceramic Implants	Straumann USA	2016	—
+2	K171769	Straumann PURE Ceramic Implants	Straumann USA, LLC (On Behalf of Institut Straumann Ag)	2017	—
+1	K132881	Z5C	Z-Systems AG	2014	—
+3	K180477	Straumann PURE Ceramic Implant System	Institut Straumann AG	2019	—
+2	K172668	W Zirconia Implants	Tav Medical, Ltd.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	1	0
2009	1	0
2012	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K120793, 2002–2025Source: 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? (5)

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
*	K062542	Z-LOOK3 Dental Implant System, Model Z3-XXX Summary page 2 …a SLM is substantially equivalent in indications and design principles to the following predicate devices: Z-Systems AG, Z-Laok3 Dental Implant System, cleared under K062542; Nobel Biocare, Zirconia Implant, cleared under K061971; and Oral Iceberg S.L., CeraRoot Implant System, cleared under K0…	Z-Systems AG	2007	—
*	K061971	Zirconia Implant Summary page 2 …principles to the following predicate devices: Z-Systems AG, Z-Laok3 Dental Implant System, cleared under K062542; Nobel Biocare, Zirconia Implant, cleared under K061971; and Oral Iceberg S.L., CeraRoot Implant System, cleared under K093595; Contour Healer, LLC. Contour Healer Temporary Abu…	Nobel Biocare AB	2007	—
*	K093595	Ceraroot Implant System Summary page 2 …ntal Implant System, cleared under K062542; Nobel Biocare, Zirconia Implant, cleared under K061971; and Oral Iceberg S.L., CeraRoot Implant System, cleared under K093595; Contour Healer, LLC. Contour Healer Temporary Abutment Cleared under KI 12099; Zimmer Dental Inc., Plastic Temporary Abu…	Oral Iceberg S.L.	2011	—
*	K112099	Contour Healer	Contour Healer, LLC	2012	—
*	K092377	Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S… Summary page 2 …eared under K093595; Contour Healer, LLC. Contour Healer Temporary Abutment Cleared under KI 12099; Zimmer Dental Inc., Plastic Temporary Abutment, cleared under K092377. The subject device and the predicate devices have the same intended use and use, have similar. technological characteristics an…	Zimmer Dental, Inc.	2009	—

Also cleared against K062542: 5 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K151328	PURE Ceramic Implants	Straumann USA	2016	12
K132881	Z5C	Z-Systems AG	2014	8
K131701	Z5MLB, Z5MLC	Z-Systems AG	2013	1
K200386	Z5-BL	Z-Systems AG	2020	0
K150021	Z5m (t)	Z-Systems AG	2015	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?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K151328 (Straumann USA, 2016) has gone furthest, with 12 descendants of its own.
5 other devices also cite its predicate K062542.

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. 2012, 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 Evo SLM implants are designed for surgical implantation into the upper and lower jaw

for the attachment of prosthodontic appliances to replace missing teeth. The Z-Look3 Evo SLM

implant system is also suitable for patients with metal allergies and the chronic diseases resulting

from them.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120793 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120793: Z-LOOK3 Evo SLM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120793

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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