510(k) · Cleared
ClearedTapered Pro Conical 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 Jun 5, 2024 as substantially equivalent to K143022 (BioHorizons Implant Systems, Inc., 2015) and 8 other predicates after a 133-day review. Its family tree reaches back 15 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 5, 2024
- Review
- 133 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 15 generations to K960026 (1996). 296 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations between
- 3 generations backK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- 2 generations backK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- 1 generation backK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
- This deviceK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260061 BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243521 Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025
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 backK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- 2 generations backK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- 1 generation backK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
- This deviceK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| −2 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| −1 | K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016 | — |
| 0 (this device) | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 | — |
| +1 | K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026 | — |
| +1 | K243521 | Conical Ti Base abutments | BioHorizons Implant Systems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 13 | 0 |
| 1994 | 13 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 8 | 0 |
| 2001 | 15 | 0 |
| 2002 | 16 | 0 |
| 2003 | 14 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 15 | 0 |
| 2007 | 19 | 0 |
| 2008 | 11 | 0 |
| 2009 | 15 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (9)
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 |
|---|---|---|---|
| * | K143022 | BioHorizons Tapered Internal ImplantsSummary page 5…ENT and Dental Devices) Reviewing Division Division of Health Technology 1B (Dental and ENT Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K143022, BioHorizons Tapered Internal Implants, BioHorizons Implant Systems Inc. Reference Devices K071638, Tapered Internal Implant Sys… | 2015 |
| * | K071638 | Biohorizons Tapered Internal Implant SystemSummary page 5…d ENT Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K143022, BioHorizons Tapered Internal Implants, BioHorizons Implant Systems Inc. Reference Devices K071638, Tapered Internal Implant System, BioHorizons Implant Systems Inc. K113779, CONELOG Implant System, Altatec GmbH K151621, BioHori… | 2007 |
| * | K113779 | Conelog Implant SystemSummary page 5…22, BioHorizons Tapered Internal Implants, BioHorizons Implant Systems Inc. Reference Devices K071638, Tapered Internal Implant System, BioHorizons Implant Systems Inc. K113779, CONELOG Implant System, Altatec GmbH K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems Inc. K172576, Tapered S… | 2012 |
| * | K151621 | BioHorizons CAD/CAM AbutmentsSummary page 5…Horizons Implant Systems Inc. Reference Devices K071638, Tapered Internal Implant System, BioHorizons Implant Systems Inc. K113779, CONELOG Implant System, Altatec GmbH K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems Inc. K172576, Tapered Short Implants, BioHorizons Implant Systems Inc… | 2016 |
| * | K172576 | BioHorizons Tapered Short ImplantsSummary page 5…l Implant System, BioHorizons Implant Systems Inc. K113779, CONELOG Implant System, Altatec GmbH K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems Inc. K172576, Tapered Short Implants, BioHorizons Implant Systems Inc. K193401, Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants, Altat… | 2017 |
| * | K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsSummary page 5…G Implant System, Altatec GmbH K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems Inc. K172576, Tapered Short Implants, BioHorizons Implant Systems Inc. K193401, Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants, Altatec GmbH K203252, Multi-unit Abutments for CONELOG, BioHorizons Imp… | 2020 |
| * | K203252 | Multi-unit Abutments for CONELOGSummary page 5…ons Implant Systems Inc. K172576, Tapered Short Implants, BioHorizons Implant Systems Inc. K193401, Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants, Altatec GmbH K203252, Multi-unit Abutments for CONELOG, BioHorizons Implant Systems Inc. 510(k) Summary… | 2021 |
| * | K223697 | MRI compatibility for existing BioHorizons dental implants and abutmentsSummary page 6…orizons Implant Systems Inc. 510(k) Summary K240187 Tapered Pro Conical Implant System Page 2 of 16 K223697, MRI compatibility for existing BioHorizons dental implants and abutments, BioHorizons Implant Systems Inc. K230108, Straumann® B… | 2023 |
| * | K230108 | Straumann® BLC and TLC ImplantsSummary page 6…Tapered Pro Conical Implant System Page 2 of 16 K223697, MRI compatibility for existing BioHorizons dental implants and abutments, BioHorizons Implant Systems Inc. K230108, Straumann® BLC and TLC Implants, Straumann USA, LLC INDICATIONS FOR USE STATEMENT BioHorizons Tapered Pro Conical dental impla… | 2023 |
What descends from it? (2)
2 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 28 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 39 of the 296 ancestors have a recall of any class.
- Of its descendants, K260061 (BioHorizons Implant Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143022.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. These dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple…
Read the full statement (239 words)
BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. These dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.
BioHorizons Tapered Short Conical dental 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. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length to implant length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.
BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.
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/K240187 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240187: Tapered Pro Conical Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240187
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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