510(k) · Cleared

Cleared

S.I.N. Dental Implant System

K200992510(k) TraditionalCleared Nov 17, 2020216-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 Nov 17, 2020 as substantially equivalent to K170392 (S.I.N. – Sistema DE Implante Nacional S.A., 2017) and 8 other predicates after a 216-day review. Its family tree reaches back 13 generations to 1990. 7 later devices descend from it.

Decided: Nov 17, 2020
Review: 216 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 9

Its longest line of descent runs back 13 generations to K894595 (1990). 245 ancestors in all, the oldest K781060 (1978). 7 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
9 generations between
3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
1 generation backK170398 S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017
This deviceK200992 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 · 2 generations on · 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 13 generations

Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
10 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
9 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
8 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
7 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
6 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
5 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
4 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
1 generation backK170398 S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017
This deviceK200992 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2021high 3 (2025) · low 0 (2024)2026

Most influential descendants

Showing 5 of 7 · 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 · 2 generations on1descendant
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
−13	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−12	K984104	Iti Dental Implant System	Straumann USA	1999	1
−11	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…	Nobel Biocare Uas, Inc.	2000	—
−10	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	27
−9	K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	—
−8	K050258	Groovy Implants	Nobel Biocare AB	2005	28
−7	K061003	SFB & CFB Implants	Nobel Biocare AB	2006	—
−6	K071370	Nobelactive Internal Connection Implant	Nobel Biocare AB	2007	4
−5	K101732	Astra Tech Implant System	Astra Tech AB	2011	—
−4	K111287	Astra Tech Implant System	Astra Tech AB	2011	—
−3	K112138	Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant	Astra Tech, Inc.	2011	—
−2	K120414	Osseospeed Plus	Astra Tech AB	2012	—
−1	K170398	S.I.N. Dental Implant System	S.I.N. – Sistema DE Implante Nacional S.A.	2017	—
0 (this device)	K200992	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
+2	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
1985	1	0
1986	2	0
1987	2	0
1988	1	0
1989	5	0
1990	6	0
1991	1	0
1992	4	0
1993	13	0
1994	10	0
1995	11	0
1996	16	0
1997	8	0
1998	8	0
1999	10	0
2000	5	0
2001	13	0
2002	17	0
2003	18	0
2004	12	0
2005	9	0
2006	9	0
2007	16	0
2008	8	0
2009	6	0
2010	7	0
2011	7	0
2012	1	0
2013	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
2025	3	0

FIG. 1 — Lineage of K200992, 1990–2025Source: 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? (9)

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
*	K170392	S.I.N. 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 K170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. Additional Predicate Devices K170398, S.I.N. Dental Im…	S.I.N. – Sistema DE Implante Nacional S.A.	2017	—
*	K170398	S.I.N. Dental Implant System Summary page 4 …s) PREDICATE DEVICE INFORMATION Primary Predicate Device K170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. Additional Predicate Devices K170398, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K163194, Neodent Implant System - GM Line, JJGC Indústr…	S.I.N. – Sistema DE Implante Nacional S.A.	2017	—
*	K163194	Neodent Implant System - GM Line Summary page 4 …mplant System, S.I.N. - Sistema de Implante Nacional S.A. Additional Predicate Devices K170398, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K101945, Neodent Implant System, JJGC Indú…	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	2017	6
*	K101945	Neodent Implant System Summary page 4 …, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K101945, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA 510(k) Summary…	Jjgc Industria E Comercio DE Materiais Dentarios S	2011	—
*	K961736	17 Angulated Abutment Summary page 5 …rcio de Materiais Dentários SA 510(k) Summary K200992 – S.I.N Dental Implant System Page 2 of 10 K961736, 17° Angulated Abutment, Nobel Biocare USA, LLC K905434, Angulated Abutment, Complete, Titanium SDCA 102, Nobelpharma USA, Inc. K…	Nobelpharma USA, Inc.	1996	—
*	K905434	Angulated Abutment, Complete,Titanium Sdca 102 Summary page 5 …mmary K200992 – S.I.N Dental Implant System Page 2 of 10 K961736, 17° Angulated Abutment, Nobel Biocare USA, LLC K905434, Angulated Abutment, Complete, Titanium SDCA 102, Nobelpharma USA, Inc. K161416, Multi-unit Abutment Plus, Nobel Biocare AB K0526…	Nobelpharma USA, Inc.	1992	—
*	K161416	Multi-unit Abutment Plus Summary page 5 …al Implant System Page 2 of 10 K961736, 17° Angulated Abutment, Nobel Biocare USA, LLC K905434, Angulated Abutment, Complete, Titanium SDCA 102, Nobelpharma USA, Inc. K161416, Multi-unit Abutment Plus, Nobel Biocare AB K052600, Zimmer Dental Incorporated, Zimmer Dental Hex-lock Prepared Abutment (Straig…	Nobel Biocare AB	2017	—
*	K052600	Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled) Summary page 5 …ated Abutment, Nobel Biocare USA, LLC K905434, Angulated Abutment, Complete, Titanium SDCA 102, Nobelpharma USA, Inc. K161416, Multi-unit Abutment Plus, Nobel Biocare AB K052600, Zimmer Dental Incorporated, Zimmer Dental Hex-lock Prepared Abutment (Straight & Angled) K110955, MegaGen Company, Limited, AnyR…	Zimmer Dental, Inc.	2005	—
*	K110955	Anyridge Internal Implant System Summary page 5 …belpharma USA, Inc. K161416, Multi-unit Abutment Plus, Nobel Biocare AB K052600, Zimmer Dental Incorporated, Zimmer Dental Hex-lock Prepared Abutment (Straight & Angled) K110955, MegaGen Company, Limited, AnyRidge Internal Implant System INDICATIONS FOR USE STATEMENT S.I.N. Dental Implant System is inten…	Megagen Co., Ltd.	2011	—
†	K193096	S.I.N. Dental Implant System	S.I.N. - Sistema DE Implante Nacional S.A.	2020	—

Also cleared against K170392: 9 other devices →

What descends from it? (7)

3 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
K252266	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	2025	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 30 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
28 of the 245 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.
9 other devices also cite its predicate K170392.

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200992 · printed Nov 3, 2026

Cite this page

510(k) Report. “K200992: S.I.N. Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200992

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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