510(k) · Cleared
ClearedDental Implants and Abutments
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 28, 2016 as substantially equivalent to K140728 (Ditron Precision, Ltd., 2014) and 1 other predicate after a 149-day review. Its family tree reaches back 15 generations to 1996. 1 later device descends from it.
- Decided
- Oct 28, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K960026 (1996). 203 ancestors in all, the oldest K820013 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations between
- 3 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 2 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 1 generation backK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
- This deviceK161497 Dental Implants and AbutmentsDitron Precision, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK233231 Dental Implants and AbutmentsDitron Dental, Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 13 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 12 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 8 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 7 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 6 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 5 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 4 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 3 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 2 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 1 generation backK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
- This deviceK161497 Dental Implants and AbutmentsDitron Precision, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K233231Dental 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 |
|---|---|---|---|---|---|
| −15 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −14 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −8 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −7 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −6 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −5 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −4 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −3 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −2 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| −1 | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi -… | Ditron Precision, Ltd. | 2014 | — |
| 0 (this device) | K161497 | Dental Implants and Abutments | Ditron Precision, Ltd. | 2016 | — |
| +1 | K233231 | 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 | 10 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Summary page 5…nt to the following predicate devices: Ditron Precision Ltd's legally marketed Dental Implants and Abutments, cleared under 510(k) number K140728 (primary predicate device), and; MIS Implants Technologies Ltd's MIS Short Implants (SEVEN), cleared under… | 2014 |
| * | K103089 | Seven Implants; Biocom Implants; Lance ImplantsSummary page 5…510(k) number K140728 (primary predicate device), and; MIS Implants Technologies Ltd's MIS Short Implants (SEVEN), cleared under 510(k) number K103089 (reference predicate device). Implant Direct LLC's Legacy3 6mm Length implants, cleared under 510(k) number… | 2011 |
| † | K131097 | LEGACY3 6MM Length Implants | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233231 | Dental Implants and Abutments | 2024 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 27 of the 203 ancestors have a recall of any class.
- Of its descendants, K233231 (Ditron Dental, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K140728.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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. » Two stage: MPI, ULT, API and CPI models * One stage: OPI model The 3.3 and 3.0 mm diameter models for One stage OPI, Two stage MPI, Two stage and API implants are intended only for…
Read the full statement (244 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.
» Two stage: MPI, ULT, API and CPI models
* One stage: OPI model
The 3.3 and 3.0 mm diameter models for One stage OPI, Two stage MPI, Two stage and API 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, ULT, API, 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, ULT, API, CPI and OPI designs are indicated for immediate loading (except for MPI and API in 6mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI and OPI are indicated for immediate loading (except for MPI and API in 6mm length) 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161497 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161497: Dental Implants and Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161497
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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