510(k) · Cleared
ClearedImplacil Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implacil DE Bortoli Material Odontologico Ltda · DZE Implant, Endosseous, Root-Form
Cleared on Feb 13, 2020 as substantially equivalent to K170398 (S.I.N. – Sistema DE Implante Nacional S.A., 2017) and 14 other predicates after a 469-day review. Its family tree reaches back 16 generations to 1996. 2 later devices descend from it.
- Decided
- Feb 13, 2020
- Review
- 469 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 16 generations to K960026 (1996). 399 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations between
- 3 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 2 generations backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- 1 generation backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- This deviceK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · cites it directly · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
- Descendant · cites it directly · 0 of its ownK192839 DSP Implant SystemD.S.P Industrial Eireli · 2021
Show all 16 generations
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 14 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 13 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 9 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 8 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 7 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 6 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 5 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 4 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 3 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 2 generations backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- 1 generation backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- This deviceK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −15 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −9 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −8 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −7 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −6 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −5 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −4 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −3 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| −2 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| −1 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| 0 (this device) | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +1 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
| +1 | K192839 | DSP Implant System | D.S.P Industrial Eireli | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 8 | 0 |
| 1991 | 4 | 0 |
| 1992 | 5 | 0 |
| 1993 | 17 | 0 |
| 1994 | 14 | 0 |
| 1995 | 16 | 0 |
| 1996 | 17 | 0 |
| 1997 | 9 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 8 | 0 |
| 2001 | 18 | 0 |
| 2002 | 23 | 0 |
| 2003 | 19 | 0 |
| 2004 | 23 | 0 |
| 2005 | 15 | 0 |
| 2006 | 25 | 0 |
| 2007 | 34 | 0 |
| 2008 | 21 | 0 |
| 2009 | 20 | 0 |
| 2010 | 12 | 0 |
| 2011 | 14 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (15)
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…Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K170398 – S.I.N. Dental Implant System – S.I.N. Sistema de Implante Nacional S.A. Reference… | 2017 |
| * | K062931 | Implus Implant SystemSummary page 4…0398 – S.I.N. Dental Implant System – S.I.N. Sistema de Implante Nacional S.A. Reference Devices K062931 – IMPLUS - LEADER Italia S.R.O K072642 - BIOMET 3i Dental Abutments and Restorative… | 2007 |
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 4…Implante Nacional S.A. Reference Devices K062931 – IMPLUS - LEADER Italia S.R.O K072642 - BIOMET 3i Dental Abutments and Restorative Components - Biomet 3i, Inc.… | 2007 |
| * | K090452 | Neoss Implant System 03.25Summary page 4…72642 - BIOMET 3i Dental Abutments and Restorative Components - Biomet 3i, Inc. K090452 - Neoss Implant System 03,25 - Neoss Limited K101207 - Neodent Implant System -JJGC… | 2009 |
| * | K101207 | Neodent Implant SystemSummary page 4…mponents - Biomet 3i, Inc. K090452 - Neoss Implant System 03,25 - Neoss Limited K101207 - Neodent Implant System -JJGC Industria e Comercio de Materiais Dentarios S.A.… | 2010 |
| * | K101945 | Neodent Implant SystemSummary page 4…- Neodent Implant System -JJGC Industria e Comercio de Materiais Dentarios S.A. K101945- Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A.… | 2011 |
| * | K133510 | Neodent Implant SystemSummary page 5…o Ltda Page 2 of 22 K183024 – Implacil Implant System K133510 - Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A.… | 2014 |
| * | K140440 | Noris Medical Dental Implants SystemSummary page 5…3510 - Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A. K140440 - Noris Medical Dental Implants System - Noris Medical, Ltd.… | 2014 |
| * | K163060 | Deep Conical (DC) Implants and AccessoriesSummary page 5…K140440 - Noris Medical Dental Implants System - Noris Medical, Ltd. K163060 -Deep Conical (DC) Implants and Accessories - Southern Implants (Pty) Ltd… | 2017 |
| * | K163634 | External Hex ImplantsSummary page 5…K163060 -Deep Conical (DC) Implants and Accessories - Southern Implants (Pty) Ltd K163634 - External Hex Implants - Southern Implants (Pty) Ltd K170392 – S.I.N. Dental Implant S… | 2017 |
| * | K170392 | S.I.N. Implant SystemSummary page 5…Implants (Pty) Ltd K163634 - External Hex Implants - Southern Implants (Pty) Ltd K170392 – S.I.N. Dental Implant System – S.I.N. Sistema de Implante Nacional S.A.… | 2017 |
| * | K170608 | UF (II) Implant SystemSummary page 5…K170392 – S.I.N. Dental Implant System – S.I.N. Sistema de Implante Nacional S.A. K170608 - UF(II) Implant System - DIO Corporation K173819 – MyPlant II Implant System Hager & M… | 2018 |
| * | K173819 | MyPlant II Implant SystemSummary page 5…Implante Nacional S.A. K170608 - UF(II) Implant System - DIO Corporation K173819 – MyPlant II Implant System Hager & Meisinger GmbH K173902 - Neodent Implant System - G… | 2018 |
| * | K173902 | Neodent Implant System – GM LineSummary page 5…t System - DIO Corporation K173819 – MyPlant II Implant System Hager & Meisinger GmbH K173902 - Neodent Implant System - GM Line - JJGC Industria e Comercio de Materiais Dentarios S… | 2018 |
| * | K180282 | MIS Internal Hex Dental Implant SystemSummary page 5…dent Implant System - GM Line - JJGC Industria e Comercio de Materiais Dentarios S.A. K180282 - MIS Internal Hex Dental Implant System -MIS Implants Technologies Ltd. INDICATIONS… | 2018 |
What descends from it? (2)
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 24 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 50 of the 399 ancestors have a recall of any class.
- Of its descendants, K202832 (Implacil DE Bortoli Material Odontologico Ltda, 2021) has gone furthest, with 0 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. 2020, 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?
Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical approach is applied, the Implacil Implant System 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/K183024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183024: Implacil 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/K183024
Report an extraction error
Are you the manufacturer?
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