510(k) · Cleared
ClearedBioHorizons Tapered Short Implants
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 Nov 22, 2017 as substantially equivalent to K121787 (BioHorizons Implant Systems, Inc., 2012) after an 86-day review. Its family tree reaches back 2 generations to 2007. 10 later devices descend from it.
- Decided
- Nov 22, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071638 (2007). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK071638 Biohorizons Tapered Internal Implant SystemBioHorizons Implant Systems, Inc. · 2007 · Recalled
- 1 generation backK121787 Biohorizons Tapered Internal Plus ImplantsBioHorizons Implant Systems, Inc. · 2012
- This deviceK172576 BioHorizons Tapered Short ImplantsBioHorizons Implant Systems, Inc. · 2017
- Descendant · cites it directly · 8 of its ownK203252 Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK213106 BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022
- Descendant · cites it directly · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK231827 BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023
- Descendant · 2 generations on · 0 of its ownK260061 BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021 · cites it directly8descendants
- K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022 · 2 generations on3descendants
- K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · cites it directly2descendants
- K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023 · 3 generations on2descendants
- K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071638 | Biohorizons Tapered Internal Implant System | BioHorizons Implant Systems, Inc. | 2007 | 2 |
| −1 | K121787 | Biohorizons Tapered Internal Plus Implants | BioHorizons Implant Systems, Inc. | 2012 | — |
| 0 (this device) | K172576 | BioHorizons Tapered Short Implants | BioHorizons Implant Systems, Inc. | 2017 | — |
| +1 | K203252 | Multi-unit Abutments for CONELOG | BioHorizons Implant Systems, Inc. | 2021 | — |
| +2 | K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
| +1 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 | — |
| +3 | K231827 | BTI Dental Implant System UnicCa® – Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. | 2023 | — |
| +2 | K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K121787 | Biohorizons Tapered Internal Plus ImplantsSummary page 4…Endosseous dental implant Classification Number: Class II (21 CFR 872.3640) Primary Product Code : DZE Predicate Devices Primary Predicate Device: 1. K121787, BioHorizons Tapered Internal Plus Implants, September 5, 2012. Reference Predicate Devices: 1. K150571, Biomet 3i T3 Short Impl… | 2012 |
| † | K150571 | 3i T3 Short Implants | 2015 |
| † | K073368 | 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant | 2008 |
| † | K050712 | 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant | 2005 |
What descends from it? (10)
3 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 10 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K203252 (BioHorizons Implant Systems, Inc., 2021) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K121787.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Tapered Short 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. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172576: BioHorizons Tapered Short Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172576
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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