510(k) · Cleared
ClearedDSP Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D.S.P Industrial Eireli · DZE Implant, Endosseous, Root-Form
Cleared on Feb 11, 2021 as substantially equivalent to K101207 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2010) and 10 other predicates after a 504-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- Feb 11, 2021
- Review
- 504 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 11
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 deviceK192839 DSP Implant SystemD.S.P Industrial Eireli · 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 deviceK192839 DSP Implant SystemD.S.P Industrial Eireli · 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) | 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 |
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? (11)
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 |
|---|---|---|---|
| * | K101207 | Neodent Implant SystemSummary page 4…on Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K101207 - Neodent Implant System -JJGC Industria e Comercio de Materiais Dentarios S.A Reference Devices… | 2010 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 4…K101207 - Neodent Implant System -JJGC Industria e Comercio de Materiais Dentarios S.A Reference Devices K023113 - Replace TiUnite Endosseous Implant - Nobel Biocare USA Inc K083561- Neoss ProActive Implant - Ne… | 2002 |
| * | K083561 | Neoss Proactive ImplantSummary page 4…Dentarios S.A Reference Devices K023113 - Replace TiUnite Endosseous Implant - Nobel Biocare USA Inc K083561- Neoss ProActive Implant - Neoss Limited K925762 - Branemark System Self-Tapping Fixture - Nobelph… | 2009 |
| * | K925762 | Branemark System Self-Tapping FixtureSummary page 4…Replace TiUnite Endosseous Implant - Nobel Biocare USA Inc K083561- Neoss ProActive Implant - Neoss Limited K925762 - Branemark System Self-Tapping Fixture - Nobelpharma USA, Inc K101945- Neodent Implant System - J… | 1993 |
| * | K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)Summary page 4…K101945- Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A. K150669 - Neoss TiBase and CoCr Abutments-Neoss Ltd. K163634 - - External Hex Implants - Southern Implants… | 2015 |
| * | K163634 | External Hex ImplantsSummary page 4…ateriais Dentarios S.A. K150669 - Neoss TiBase and CoCr Abutments-Neoss Ltd. K163634 - - External Hex Implants - Southern Implants (Pty) Ltd. K170398 - S.I.N. Dental Implant System -… | 2017 |
| * | K170398 | S.I.N. Dental Implant SystemSummary page 4…Neoss TiBase and CoCr Abutments-Neoss Ltd. K163634 - - External Hex Implants - Southern Implants (Pty) Ltd. K170398 - S.I.N. Dental Implant System - S.I.N. Sistema de Implante Nacional S.A… | 2017 |
| * | K183024 | Implacil Implant System Cleared while this submission was under review Summary page 4…K170398 - S.I.N. Dental Implant System - S.I.N. Sistema de Implante Nacional S.A K183024 – Implacil Implant System -Implacil de Bortoli Material Odontologico Ltda… | 2020 |
| * | K123022 | Neodent Implant SystemSummary page 22…13 is for substantial equivalence of the height of the machined collar. The subject HE WAYFIT and PROPFIT implants are substantially equivalent to the reference devices K123022 and K163634. The K163634 is for substantial equivalence of the range of dimensions (diameter and length). The K023113 is for subs… | 2013 |
| * | K062931 | Implus Implant SystemSummary page 22…3113 is for substantial equivalence of the height of the machined collar. The subject HE PROPFIT implants are substantially equivalent to the reference devices K023113, K062931 and K163634. The K163634 is for substantial equivalence of the range of dimensions (diameter and length). The K023113 is for subs… | 2007 |
| * | K101945 | Neodent Implant SystemSummary page 4…ss ProActive Implant - Neoss Limited K925762 - Branemark System Self-Tapping Fixture - Nobelpharma USA, Inc K101945- Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A.… | 2011 |
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 5 companies; a new generation was cleared every 10 months on median.
- 50 of the 400 ancestors have a recall of any class.
- 5 other devices also cite its predicate K101207.
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?
The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for
prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for
single or multiple unit restorations, and may be loaded immediately when good primary stability is
achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192839: DSP 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/K192839
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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