510(k) · Cleared
ClearedBioHorizons CEREC Compatible Ti-Bases
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioHorizons Implant Systems, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 26, 2026 as substantially equivalent to K240187 (BioHorizons Implant Systems, Inc., 2024) after a 169-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Jun 26, 2026
- Review
- 169 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K960026 (1996). 297 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations between
- 3 generations backK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- 2 generations backK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
- 1 generation backK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
- This deviceK260061 BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 14 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 13 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 9 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 8 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 7 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 6 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 5 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 4 generations backK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- 3 generations backK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- 2 generations backK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
- 1 generation backK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
- This deviceK260061 BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −15 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −9 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −8 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −7 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −6 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −5 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −4 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| −3 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| −2 | K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016 | — |
| −1 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 | — |
| 0 (this device) | K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026 | — |
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 |
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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K240187 | Tapered Pro Conical Implant SystemSummary page 5…of Health Technology 1B (Dental and ENT Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device—Chairside Ti-Bases & Conical CEREC Compatible Ti Bases K240187, BioHorizons Tapered Pro Conical Implant System (TPC) Reference Device— Chairside Ti-Bases & Conical CEREC Compatible Ti Bases… | 2024 |
| † | K171532 | TruBase S | 2018 |
| † | K250295 | Dentsply Sirona Titanium Bases system | 2025 |
| † | K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | 2023 |
| † | K151621 | BioHorizons CAD/CAM Abutments | 2016 |
| † | K143337 | CONELOG Titanium base CAD/CAM | 2015 |
| † | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | 2020 |
| † | K234018 | CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System | 2024 |
| † | K022476 | Relyx Rmgip | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 39 of the 297 ancestors have a recall of any class.
- 1 other device also cites its predicate K240187.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
BioHorizons Chairside Ti-Bases 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. BioHorizons 3.0 Chairside Ti-Bases are limited for use as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors when used with 3.4mm diameter implants. All…
Read the full statement (158 words)
BioHorizons Chairside Ti-Bases 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.
BioHorizons 3.0 Chairside Ti-Bases are limited for use as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors when used with 3.4mm diameter implants.
All digitally designed abutments and/or copings for use with Chairside Ti-Bases are to be designed using Sirona CEREC® Software and manufactured using a Sirona CEREC® MC XL milling unit.
Conical CEREC Compatible Ti Bases 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 and/or copings for use with Conical CEREC Compatible Ti Bases are to be designed using Sirona CEREC® Software and manufactured using a Sirona CEREC® MC XL milling unit.
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/K260061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260061: BioHorizons CEREC Compatible Ti-Bases.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260061
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026