510(k) · Cleared
Recalled · 2010Biohorizons Single-Stage Implant
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 Dec 2, 2005 as substantially equivalent to K020645 (BioHorizons Implant Systems, Inc., 2002) and 1 other predicate after a 22-day review. Its family tree reaches back 8 generations to 1996. 77 later devices descend from it. It has been recalled once.
- Decided
- Dec 2, 2005
- Review
- 22 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K960026 (1996). 10 ancestors in all. 77 later devices descend from it, 2 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 deviceK053152 Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc. · 2005
- Descendant · cites it directly · 76 of its ownK073282 Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008
- Descendant · 2 generations on · 73 of its ownK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- Descendant · 3 generations on · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · 3 generations on · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K073282Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008 · cites it directly76descendants
- K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010 · 2 generations on73descendants
- K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · 3 generations on45descendants
- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 4 generations on36descendants
- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · 3 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) | K053152 | Biohorizons Single-Stage Implant | BioHorizons Implant Systems, Inc. | 2005 | — |
| +1 | K073282 | Biohorizons Single-Stage Implant System | BioHorizons Implant Systems, Inc. | 2008 | — |
| +2 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| +3 | 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 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K020645 | Modification to the Maestro SystemSummary page 1…ic attachments Classification Number: Class II Predicate Devices 1. The Maestro System extended collar implants, documented under 510(k) number K020645, concurrence date of March 15, 2002. 2. The Prodigy System internal-connection implants, documented under 51 0(k) number K0424… | 2002 |
| * | K042429 | The Prodigy System Dental ImplantsSummary page 1…ts, documented under 510(k) number K020645, concurrence date of March 15, 2002. 2. The Prodigy System internal-connection implants, documented under 51 0(k) number K042429, concurrence date of September 16, 2005. Device Description The RioHorizons Single-stage dental implants are machined titanium,… | 2004 |
What descends from it? (77)
See all 772 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2010 | Not classified | Z-0321-2011 | Other | Healing abutment may not fully seat on the implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K073282 (BioHorizons Implant Systems, Inc., 2008) has gone furthest, with 76 descendants of its own.
- 3 other devices also cite its predicate K020645.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BioHorizons Single-stage implant may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053152 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053152: Biohorizons Single-Stage Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053152
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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