510(k) · Cleared
ClearedWINSIX Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosaf IN S.R.L. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 28, 2015 as substantially equivalent to K073458 (Btlock Srl, 2008) and 7 other predicates after a 418-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Jan 28, 2015
- Review
- 418 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K925765 (1993). 97 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · Recalled
- This deviceK133733 WINSIX Implant SystemBiosaf IN S.R.L. · 2015
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · Recalled
- This deviceK133733 WINSIX Implant SystemBiosaf IN S.R.L. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | Implant Innovations, Inc. | 2007 | 5 |
| 0 (this device) | K133733 | WINSIX Implant System | Biosaf IN S.R.L. | 2015 | — |
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 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 10 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K073458 | BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Summary page 4…: Applicant Device name 510(k) Number BT Lock BT Lock Implant System K073458 AstraTech Microtherad Osseosped K053384 Nobel Biocare… | 2008 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 4…umber BT Lock BT Lock Implant System K073458 AstraTech Microtherad Osseosped K053384 Nobel Biocare Nobel Speedy Implants K050406 Implant Innovation 3i… | 2006 |
| * | K050406 | Nobelspeedy ImplantsSummary page 4…73458 AstraTech Microtherad Osseosped K053384 Nobel Biocare Nobel Speedy Implants K050406 Implant Innovation 3i Osseotite Dental Implants K063286 Implant Innovation 3i Osse… | 2005 |
| * | K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteSummary page 4…53384 Nobel Biocare Nobel Speedy Implants K050406 Implant Innovation 3i Osseotite Dental Implants K063286 Implant Innovation 3i Osseotite Certain Dental Implants K063341 IT… | 2007 |
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 4…50406 Implant Innovation 3i Osseotite Dental Implants K063286 Implant Innovation 3i Osseotite Certain Dental Implants K063341 ITI Dental Implant System Straumann USA… | 2007 |
| * | K033922 | Modification to Iti Dental Implant SystemSummary page 4…al Implants K063341 ITI Dental Implant System Straumann USA K033922 (Strauman Plus Implant) BIOSAF IN S.R.L.… | 2004 |
| * | K073628 | Synocta AbutmentsSummary page 5…BT Lock Implant System K073458 Straumann USA Straumann RN synOcta K073628 Nobel Biocare Multi Unit Abutment for Astratech, K061477… | 2008 |
| * | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsSummary page 5…Straumann RN synOcta K073628 Nobel Biocare Multi Unit Abutment for Astratech, K061477 Camlog and Ankilos Implant System 4. Device Description The family of WINSIX Implant… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 12 of the 97 ancestors have a recall of any class.
- 1 other device also cites its predicate K073458.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
WINSIX Implant System is indicated for single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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/K133733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133733: WINSIX 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/K133733
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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