510(k) · Cleared
ClearedMpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and PR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ditron Precision, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 17, 2014 as substantially equivalent to K063364 (Alpha-Bio Tec, Ltd., 2007) and 2 other predicates after a 207-day review. Its family tree reaches back 14 generations to 1996. 6 later devices descend from it.
- Decided
- Oct 17, 2014
- Review
- 207 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K960026 (1996). 200 ancestors in all, the oldest K820013 (1982). 6 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations between
- 3 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 2 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 1 generation backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- This deviceK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · cites it directly · 1 of its ownK161497 Dental Implants and AbutmentsDitron Precision, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243066 Dental Implants and AbutmentsDitron Dental, Ltd. · 2024
Show all 14 generations
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 12 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 11 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 7 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 6 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 5 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 4 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 3 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 2 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 1 generation backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- This deviceK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K203240AccelX AbutmentsIntegrated Dental Systems, LLC · 2021 · cites it directly2descendants
- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · 2 generations on1descendant
- K161497Dental Implants and AbutmentsDitron Precision, Ltd. · 2016 · cites it directly1descendant
- K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026 · 3 generations on0descendants
- K243066Dental Implants and AbutmentsDitron Dental, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −13 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −7 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −6 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −5 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −4 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −3 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −2 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −1 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| 0 (this device) | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi -… | Ditron Precision, Ltd. | 2014 | — |
| +1 | K203240 | AccelX Abutments | Integrated Dental Systems, LLC | 2021 | — |
| +2 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +1 | K161497 | Dental Implants and Abutments | Ditron Precision, Ltd. | 2016 | — |
| +3 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
| +1 | K243066 | Dental Implants and Abutments | Ditron Dental, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 13 | 0 |
| 1995 | 9 | 0 |
| 1996 | 13 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 12 | 0 |
| 2000 | 8 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 5 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 5…nd Abutments are substantially equivalent to the following Predicate Devices: 4.1 Alpha-Bio Tec® Dental Implant System (by Alpha-Bio Tec Ltd) cleared under K063364; product code DZE (Implant, Endosseous, Root-Form). 4.2 AB Dental Abutments (by AB Dental Ltd) cleared under K112440; product… | 2007 |
| * | K112440 | AB Dental Devices Implants and AccessoriesSummary page 5…ystem (by Alpha-Bio Tec Ltd) cleared under K063364; product code DZE (Implant, Endosseous, Root-Form). 4.2 AB Dental Abutments (by AB Dental Ltd) cleared under K112440; product code NHA Endosseous Dental Implant Abutment. 4.3 Prismatik Dentalcraft Multi-Unit Abutments with Angulations 1… | 2012 |
| * | K121688 | Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant SystemSummary page 5…t Abutment. 4.3 Prismatik Dentalcraft Multi-Unit Abutments with Angulations 17o and 30o for Tapered Implant System (by Prismatik Dentalcraft Inc) cleared under K121688; product code NHA Endosseous dental implant. 5. Intended Use/Indications for Use: The Ditron Dental Implant and Abutme… | 2012 |
What descends from it? (6)
4 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 18 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 27 of the 200 ancestors have a recall of any class.
- Of its descendants, K203240 (Integrated Dental Systems, LLC, 2021) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K063364.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient’s chewing function. x Two stage: MPI, CPI models x One stage: OPI model One stage and One piece OPI 3.3 and 3.0 mm diameter implants are intended only for the incisors and cuspids of the maxilla and…
Read the full statement (213 words)
Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative
applications for placement in the bone of the upper or lower jaw to provide support for prosthetic
devices, such as artificial teeth, in order to restore the patient’s chewing function.
x Two stage: MPI, CPI models
x One stage: OPI model
One stage and One piece OPI 3.3 and 3.0 mm diameter implants are intended only for the incisors
and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using
multiple implants.
Two stage and One stage implants for temporary or long-term use: MPI, CPI, OPI are self-
tapping titanium threaded screws indicated for long term intra bony applications. They permit
immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis
and protection of graft sites.
MPI, CPI and OPI designs are indicated for immediate loading when good primary stability is
achieved and with appropriate occlusal loading.
MPI, CPI and OPI are indicated for immediate loading in single tooth restorations when good
primary stability is achieved with appropriate occlusal loading.
The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a
splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees
of parallelism for a splinted restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140728 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140728: Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and PR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140728
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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