510(k) · Cleared
ClearedBonafix Implant Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zentek Medical, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 15, 2025 as substantially equivalent to K221673 (Zentek Medical, LLC, 2023) after a 173-day review. Its family tree reaches back 21 generations to 1996.
- Decided
- Oct 15, 2025
- Review
- 173 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K960026 (1996). 324 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 21 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations between
- 3 generations backK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- 2 generations backK212108 Dynamic TiBaseTalladium España, SL · 2021
- 1 generation backK221673 Bonafix TiBaseZentek Medical, LLC · 2023
- This deviceK251294 Bonafix Implant AbutmentsZentek Medical, LLC · 2025
Show all 21 generations
- Root · 21 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 20 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 19 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 18 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 17 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 16 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 14 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 13 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 12 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 11 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 10 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 9 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 8 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 7 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 6 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 5 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 4 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 3 generations backK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- 2 generations backK212108 Dynamic TiBaseTalladium España, SL · 2021
- 1 generation backK221673 Bonafix TiBaseZentek Medical, LLC · 2023
- This deviceK251294 Bonafix Implant AbutmentsZentek Medical, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −20 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −19 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −18 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −17 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −16 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −14 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −13 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −12 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −11 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −10 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −9 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −8 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −7 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −6 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −5 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −4 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −3 | K202026 | Blue Sky Bio CAD-CAM Abutments | Blue Sky Bio, LLC | 2020 | — |
| −2 | K212108 | Dynamic TiBase | Talladium España, SL | 2021 | — |
| −1 | K221673 | Bonafix TiBase | Zentek Medical, LLC | 2023 | — |
| 0 (this device) | K251294 | Bonafix Implant Abutments | Zentek Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 17 | 0 |
| 2007 | 24 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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 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 |
|---|---|---|---|
| * | K221673 | Bonafix TiBaseSummary page 6…Regulation Number 872.3630 Product Code NHA IV) Predicate Device 510(k) Number K221673 Applicant ZENTEK MEDICAL LLC Trade Name Bonafix TiBase… | 2023 |
| † | K240570 | IPD Dental Implant Abutments | 2024 |
| † | K242819 | IPD Dental Implant Abutments | 2024 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K073142 | Nobelreplace Hexagonal Implant | 2008 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K130222 | Straumann Dental Implant System | 2013 |
| † | K101732 | Astra Tech Implant System | 2011 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K191256 | Straumann BLX Ø3.5 mm Implants | 2019 |
| † | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | 2018 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K140091 | Xpeed Anyridge Internal Implant Sysyem | 2014 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K120243 | GAM-200 | 2012 |
| † | K193352 | AbutmentCAD | 2021 |
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 29 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 44 of the 324 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Bonafix Implant Abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient. Compatible Implant Systems Dental implant System Implant Body Diameter (mm) Platform Diameter Neodent GM 3.5, 3.75, 4.0, 4.3, 5.0 Single Platform Nobel Replace 3.5 NP 4.3 RP 5.0 WP Biomed 3I Certain 3.4 3.4 4.1 4.1 5.0 5.0 Straumann Tissue Level 4.1, 4.8…
Read the full statement (133 words)
Bonafix Implant Abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Compatible Implant Systems
Dental implant System Implant Body Diameter (mm) Platform Diameter
Neodent GM 3.5, 3.75, 4.0, 4.3, 5.0 Single Platform
Nobel Replace 3.5 NP
4.3 RP
5.0 WP
Biomed 3I Certain 3.4 3.4
4.1 4.1
5.0 5.0
Straumann Tissue Level 4.1, 4.8 RN
4.8 WN
Astratech 3.5, 4.0 Small
4.5, 5.0 Large
Straumann BLX 3.5, 3.75, 4.0, 4.5 RB
Megagen AnyRidge 4.0, 4.4 Regular
4.9, 5.4, 5.9 Wide
Megagen AnyOne 3.9 3.5
4.3, 4.8, 5.3, 6.3 3.9
All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to be sent to a Bonafix validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251294: Bonafix Implant Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251294
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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