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 Nov 21, 2017 as substantially equivalent to K051859 (Sin Sistema DE Implante Nacional Ltda, 2005) and 5 other predicates after a 285-day review. Its family tree reaches back 12 generations to 1990. 17 later devices descend from it.
- Decided
- Nov 21, 2017
- Review
- 285 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K894595 (1990). 169 ancestors in all, the oldest K781060 (1978). 17 later devices descend from it, 6 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK170398 S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017
- Descendant · cites it directly · 8 of its ownK203725 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
- Descendant · cites it directly · 8 of its ownK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
- Descendant · cites it directly · 7 of its ownK200992 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
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 4 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK170398 S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · cites it directly8descendants
- 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 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −4 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| 0 (this device) | K170398 | S.I.N. Dental Implant System | S.I.N. – Sistema DE Implante Nacional S.A. | 2017 | — |
| +1 | K203725 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021 | — |
| +1 | K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
| +1 | 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 |
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 |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K051859 | Sistema DE Implante Nacional (S.I.N.); Dental Implant SystemSummary page 4…HA Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K051859 Sistema de Implante Nacional Dental Implant System Sistema de Implante Nacional, Ltda. 510(k) Summary… | 2005 |
| * | K120414 | Osseospeed PlusSummary page 5…I.N. Dental Implant System Page 2 of 6 K170398 Reference Predicates K120414 OsseoSpeed™ Plus Astra Tech AB K072570 NobelActive Multi Unit Abutment… | 2012 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 5…K170398 Reference Predicates K120414 OsseoSpeed™ Plus Astra Tech AB K072570 NobelActive Multi Unit Abutment Nobel Biocare AB K072363 BIOMET 3i NanoTite™ Dental Im… | 2007 |
| * | K072363 | Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexSummary page 5…OsseoSpeed™ Plus Astra Tech AB K072570 NobelActive Multi Unit Abutment Nobel Biocare AB K072363 BIOMET 3i NanoTite™ Dental Implants Biomet 3i, Inc. K092035 Bicon Implants with a 2.5mm In… | 2008 |
| * | K092035 | Bicon Implants with a 2.5MM Internal ConnectionSummary page 5…NobelActive Multi Unit Abutment Nobel Biocare AB K072363 BIOMET 3i NanoTite™ Dental Implants Biomet 3i, Inc. K092035 Bicon Implants with a 2.5mm Internal Connection Bicon, L.L.C K101945 Neodent Implant System… | 2009 |
| * | K101945 | Neodent Implant SystemSummary page 5…BIOMET 3i NanoTite™ Dental Implants Biomet 3i, Inc. K092035 Bicon Implants with a 2.5mm Internal Connection Bicon, L.L.C K101945 Neodent Implant System JJGC Industria e Comercio de Materiais… | 2011 |
What descends from it? (17)
See all 176 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 27 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 169 ancestors have a recall of any class.
- Of its descendants, K203725 (S.I.N. - Sistema DE Implante Nacional S.A., 2021) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K051859.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
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. Revolution Compact with a 6 mm length is intended for delayed loading only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170398: 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/K170398
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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