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 May 26, 2021 as substantially equivalent to K183024 (Implacil DE Bortoli Material Odontologico Ltda, 2020) after a 243-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- May 26, 2021
- Review
- 243 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K960026 (1996). 400 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations between
- 3 generations backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- 2 generations backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- 1 generation backK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- This deviceK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
Show all 17 generations
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 15 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 14 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 10 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 9 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 8 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 7 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 6 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 5 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 4 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 3 generations backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- 2 generations backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- 1 generation backK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- This deviceK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −16 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −10 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −9 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −8 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −7 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −6 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −5 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −4 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| −3 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| −2 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| −1 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| 0 (this device) | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 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 |
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 |
|---|---|---|---|
| * | K183024 | Implacil Implant SystemSummary page 4…Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K183024 – Implacil Implant System – Implacil de Bortoli Material Odontologico Ltda Reference Devi… | 2020 |
| † | K170392 | S.I.N. Implant System | 2017 |
| † | K192839 | DSP Implant System | 2021 |
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 25 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 50 of the 400 ancestors have a recall of any class.
- 1 other device also cites its predicate K183024.
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?
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 as stated in the FDA summary.
https://510kreport.com/device/K202832 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202832: Implacil Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202832
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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