510(k) Report

510(k) · Cleared

Cleared

Sistema DE Implante Nacional (S.I.N.); Dental Implant System

K051859510(k) TraditionalCleared Sep 23, 200577-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

Sin Sistema DE Implante Nacional Ltda · DZE Implant, Endosseous, Root-Form

Cleared on Sep 23, 2005 after a 77-day review. The FDA summary names no predicate by number. 22 later devices descend from it.

Decided
Sep 23, 2005
Review
77 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

22 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2020: 3 descendants cleared2025: 4 descendants cleared2024: 3 descendants cleared2022: 3 descendants cleared2023: 3 descendants cleared2021: 4 descendants cleared20052010201520202025
  1. This deviceK051859 Sistema DE Implante Nacional (S.I.N.); Dental Implant SystemSin Sistema DE Implante Nacional Ltda · 2005
  2. Descendant · cites it directly · 17 of its ownK170398 S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017
  3. Descendant · cites it directly · 16 of its ownK170392 S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017
  4. Descendant · 2 generations on · 8 of its ownK203725 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
  5. Descendant · cites it directly · 8 of its ownK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
  6. Descendant · 2 generations on · 7 of its ownK200992 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2017: 22020: 32021: 42022: 32023: 32024: 32025: 4
2017high 4 (2021) · low 0 (2018)2026

Most influential descendants

Showing 5 of 22 · See all
  • K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017 · cites it directly17descendants
  • K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017 · cites it directly16descendants
  • K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · 2 generations on8descendants
  • K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · cites it directly8descendants
  • K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051859Sistema DE Implante Nacional (S.I.N.); Dental Implant SystemSin Sistema DE Implante Nacional Ltda2005—
+1K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.2017—
+1K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.2017—
+2K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.2021—
+1K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.2020—
+2K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
202030
202140
202230
202330
202430
202540
FIG. 1 — Lineage of K051859, 2005–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717
K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716
K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208

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, K170398 (S.I.N. – Sistema DE Implante Nacional S.A., 2017) has gone furthest, with 17 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

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
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

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

The Sistema de Implante Nacional Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Implants may be placed immediately after tooth extraction or following bone healing. Restorations supported by two or more Sistema de'lmplante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved.

Indications for use as stated in the FDA summary.

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K051859 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051859: Sistema DE Implante Nacional (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/K051859

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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