510(k) · Cleared

Cleared

S.I.N. Dental Implant System

K193096510(k) TraditionalCleared May 14, 2020189-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

S.I.N. - Sistema DE Implante Nacional S.A. · DZE Implant, Endosseous, Root-Form

Cleared on May 14, 2020 as substantially equivalent to K170398 (S.I.N. – Sistema DE Implante Nacional S.A., 2017) and 3 other predicates after a 189-day review. Its family tree reaches back 17 generations to 1996. 8 later devices descend from it.

Decided: May 14, 2020
Review: 189 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 4

Its longest line of descent runs back 17 generations to K960026 (1996). 364 ancestors in all, the oldest K781060 (1978). 8 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
13 generations between
3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
1 generation backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
This deviceK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
Descendant · cites it directly · 5 of its ownK211921 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
Descendant · 2 generations on · 4 of its ownK222231 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · Recalled
Descendant · cites it directly · 1 of its ownK221453 S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2022
Descendant · cites it directly · 0 of its ownK252266 S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025
Descendant · 3 generations on · 0 of its ownK251262 S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025

Show all 17 generations

Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
16 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
15 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
14 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
13 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
12 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
11 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
10 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
9 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
8 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
7 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
6 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
5 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
4 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
1 generation backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
This deviceK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2021high 3 (2025) · low 0 (2026)2026

Most influential descendants

Showing 5 of 8 · See all

K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · cites it directly5descendants
K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · 2 generations on4descendants
K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2022 · cites it directly1descendant
K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025 · cites it directly0descendants
K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−17	K960026	Biohorizons Dental Implant System	BioHorizons Implant Systems, Inc.	1996	—
−16	K964330	Biohorizons Dental Implant System (Name Subject to Change)	BioHorizons Implant Systems, Inc.	1997	—
−15	K972313	The Maestro System	BioHorizons Implant Systems, Inc.	1997	—
−14	K020133	Modification to the Maestro System	BioHorizons Implant Systems, Inc.	2002	—
−13	K020645	Modification to the Maestro System	BioHorizons Implant Systems, Inc.	2002	—
−12	K022795	Modification to the Maestro System	BioHorizons Implant Systems, Inc.	2002	—
−11	K030463	Modification to the Maestro System	BioHorizons Implant Systems, Inc.	2003	1
−10	K032351	The Maestro System 3.0MM Diameter Implant	BioHorizons Implant Systems, Inc.	2003	—
−9	K041938	Maximus OS (Overdenture System)	BioHorizons Implant Systems, Inc.	2004	2
−8	K063364	Alpha Bio Dental Implant System	Alpha-Bio Tec, Ltd.	2007	—
−7	K081653	Mdi Mii One-Piece Implant, 2.9MM	Imtec Corp.	2008	1
−6	K123022	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2013	—
−5	K133510	Neodent Implant System	Jj Industria E Comercio DE Materiais Dentarios SA	2014	—
−4	K133592	Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…	Neodent USA, Inc.	2014	—
−3	K150367	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2015	—
−2	K170588	DESS Dental Smart Solutions	Terrats Medical SL	2017	—
−1	K183518	Preat Abutments	Preat Corporation	2019	3
0 (this device)	K193096	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2020	—
+1	K211921	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2021	—
+2	K222231	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2022	1
+1	K221453	S.I.N. Dental Implant System	S.I.N. – Sistema DE Implante Nacional S.A.	2022	—
+1	K252266	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	2025	—
+3	K251262	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1982	1	0
1984	1	0
1985	1	0
1986	2	0
1987	2	0
1988	1	0
1989	5	0
1990	7	0
1991	3	0
1992	5	0
1993	13	0
1994	14	0
1995	15	0
1996	17	0
1997	7	0
1998	8	0
1999	12	0
2000	11	0
2001	18	0
2002	19	0
2003	18	0
2004	18	0
2005	17	0
2006	20	0
2007	27	0
2008	20	0
2009	19	0
2010	13	0
2011	13	0
2012	6	0
2013	4	0
2014	3	0
2015	2	0
2016	1	0
2017	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0
2022	2	0
2023	1	0
2024	1	0
2025	3	0

FIG. 1 — Lineage of K193096, 1996–2025Source: 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? (4)

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
*	K170398	S.I.N. Dental Implant System Summary page 4 …ENT and Dental Devices) Reviewing Division Division of Health Technology 1 B (Dental Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device: K170398, S.I.N. Dental Implant System, S.I.N. – Sistema de Implante Nacional S.A. 510(k) Summary…	S.I.N. – Sistema DE Implante Nacional S.A.	2017	—
*	K170392	S.I.N. Implant System Summary page 5 …S.I.N Dental Implant System Page 2 of 14 K193096 Reference Devices: K170392, S.I.N. Dental Implant System, S.I.N. – Sistema de Implante Nacional S.A. K051859, Sistema de Implante Nacional Dental Implant Sy…	S.I.N. – Sistema DE Implante Nacional S.A.	2017	—
*	K051859	Sistema DE Implante Nacional (S.I.N.); Dental Implant System Summary page 5 …K193096 Reference Devices: K170392, S.I.N. Dental Implant System, S.I.N. – Sistema de Implante Nacional S.A. K051859, Sistema de Implante Nacional Dental Implant System, Sistema de Implante Nacional Ltda K183518, Preat Abutments, Preat Corporatio…	Sin Sistema DE Implante Nacional Ltda	2005	—
*	K183518	Preat Abutments Summary page 5 …, S.I.N. Dental Implant System, S.I.N. – Sistema de Implante Nacional S.A. K051859, Sistema de Implante Nacional Dental Implant System, Sistema de Implante Nacional Ltda K183518, Preat Abutments, Preat Corporation INDICATIONS FOR USE STATEMENT S.I.N. Dental Implant System is intended for placement in the…	Preat Corporation	2019	3

Also cleared against K170398: 5 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K211921	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2021	5
K221453	S.I.N. Dental Implant System	S.I.N. – Sistema DE Implante Nacional S.A.	2022	1
K252266	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	2025	0
K231566	ICX-Implant System	Medentis Medical GmbH	2024	0
K230069	S.I.N. Dental Implant System	S.I.N. – Sistema DE Implante Nacional S.A.	2023	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 24 years and passes through 9 companies; a new generation was cleared every 10 months on median.
50 of the 364 ancestors have a recall of any class.
Of its descendants, K211921 (S.I.N. - Sistema DE Implante Nacional S.A., 2021) has gone furthest, with 5 descendants of its own.
5 other devices also cite its predicate K170398.

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. 2020, 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?

S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K193096 · printed Nov 6, 2026

Cite this page

510(k) Report. “K193096: S.I.N. 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/K193096

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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