510(k) · Cleared
ClearedS.I.N. Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.I.N. - Sistema DE Implante Nacional S.A. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 23, 2021 as substantially equivalent to K170398 (S.I.N. – Sistema DE Implante Nacional S.A., 2017) after a 184-day review. Its family tree reaches back 13 generations to 1990. 8 later devices descend from it.
- Decided
- Jun 23, 2021
- Review
- 184 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894595 (1990). 170 ancestors in all, the oldest K781060 (1978). 8 later devices descend from it, 2 citing it directly.
- 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 deviceK203725 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
- Descendant · cites it directly · 4 of its ownK222231 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · Recalled
- Descendant · cites it directly · 2 of its ownK231127 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2023
- Descendant · 2 generations on · 1 of its ownK221453 S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2022
- Descendant · 2 generations on · 0 of its ownK251129 S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda · 2025
- Descendant · 2 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 deviceK203725 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · cites it directly4descendants
- K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2023 · cites it directly2descendants
- K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2022 · 2 generations on1descendant
- K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda · 2025 · 2 generations on0descendants
- K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda · 2025 · 2 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) | K203725 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021 | — |
| +1 | K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2022 | 1 |
| +1 | K231127 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2023 | — |
| +2 | K221453 | S.I.N. Dental Implant System | S.I.N. – Sistema DE Implante Nacional S.A. | 2022 | — |
| +2 | K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | 2025 | — |
| +2 | 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 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K170398 | S.I.N. Dental Implant SystemSummary 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. Reference Devices K160119, NobelSpeedy® Groovy, Nobel… | 2017 |
| † | K160119 | NobelSpeedy Groovy | 2016 |
| † | K173343 | Zygomatic Implant System | 2018 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 170 ancestors have a recall of any class.
- Of its descendants, K222231 (S.I.N. - Sistema DE Implante Nacional S.A., 2022) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K170398.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 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?
For Strong SW HE Implants 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. S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm when…
Read the full statement (156 words)
For Strong SW HE Implants
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.
S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
For Zygomatic Implants and Abutments
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are 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/K203725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203725: 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/K203725
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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