510(k) · Cleared
Recalled · Class II · 2015Biohorizons Internal Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioHorizons Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 8, 2008 as substantially equivalent to K042429 (BioHorizons Implant Systems, Inc., 2004) and 1 other predicate after an 80-day review. Its family tree reaches back 8 generations to 1996. 111 later devices descend from it. It has been recalled once.
- Decided
- Feb 8, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K960026 (1996). 11 ancestors in all. 111 later devices descend from it, 8 citing it directly.
- Root · 8 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 6 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 5 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 2 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 1 generation backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
- This deviceK073268 Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008
- Descendant · cites it directly · 103 of its ownK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- Descendant · cites it directly · 73 of its ownK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- Descendant · cites it directly · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · 2 generations on · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 111 · See all- K093321Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · cites it directly103descendants
- K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010 · cites it directly73descendants
- K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · cites it directly45descendants
- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 2 generations on36descendants
- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −7 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −6 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −5 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −2 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −1 | K042429 | The Prodigy System Dental Implants | BioHorizons Implant Systems, Inc. | 2004 | — |
| 0 (this device) | K073268 | Biohorizons Internal Implant System | BioHorizons Implant Systems, Inc. | 2008 | — |
| +1 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| +1 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| +1 | 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 | — |
| +2 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 12 | 0 |
| 2023 | 11 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K042429 | The Prodigy System Dental ImplantsSummary page 1…: Class 11 (21 CFR 872.3640) :~dicate Devices t.:BioHorizons Internal Implant System (formerly "The Prodigy System Dental Implants"), documented under 510(k) number K042429, concurrence date of ~Septmber16, 2004. *4:BioHorizons Tapered Internal Implant System, documented under 510(k) number… | 2004 |
| * | K071638 | Biohorizons Tapered Internal Implant SystemSummary page 1…documented under 510(k) number K042429, concurrence date of ~Septmber16, 2004. *4:BioHorizons Tapered Internal Implant System, documented under 510(k) number > K071638, concurrence date of October 10, 2007. vice Description Horizons Internal Implants are machined titanium, screw-for… | 2007 |
What descends from it? (111)
See all 1118 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093321 | Biohorizons Laser-Lok 3.0 Implant System | 2010 | 103 |
| K100985 | Biohorizons Simple Solutions with Laser-Lok | 2010 | 73 |
| K103691 | Biohorizons Abutments for Zimmer | 2011 | 45 |
| K142174 | Biomate Dental Implant System | 2015 | 1 |
| K102635 | Apolonia Laser Implant System | 2011 | 1 |
| K133613 | Intra-Lock Dental Implants | 2014 | 0 |
| K121873 | Avinent Dental Implant System | 2013 | 0 |
| K131526 | Sfi-Bar | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2015 | Class II | Z-0391-2016 | Employee error | An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K093321 (BioHorizons Implant Systems, Inc., 2010) has gone furthest, with 103 descendants of its own.
- 5 other devices also cite its predicate K042429.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
BioHorizons Internal Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention.
BioHorizons Internal Implants may be restored immediately with a temporary prosthesis that is not in functional occlusion, or when splinted together for multiple tooth replacement, or when stabilized with an overdenture supported by multiple implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073268: Biohorizons Internal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073268
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