510(k) · Cleared
ClearedBonafix TiBase
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 Jul 14, 2023 as substantially equivalent to K212108 (Talladium España, SL, 2021) after a 400-day review. Its family tree reaches back 20 generations to 1996. 1 later device descends from it.
- Decided
- Jul 14, 2023
- Review
- 400 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K960026 (1996). 323 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations between
- 3 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 2 generations backK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- 1 generation backK212108 Dynamic TiBaseTalladium España, SL · 2021
- This deviceK221673 Bonafix TiBaseZentek Medical, LLC · 2023
- Descendant · cites it directly · 0 of its ownK251294 Bonafix Implant AbutmentsZentek Medical, LLC · 2025
Show all 20 generations
- Root · 20 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 19 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 18 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 17 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 16 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 13 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 12 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 11 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 10 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 9 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 8 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 7 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 6 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 5 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 4 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 3 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 2 generations backK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- 1 generation backK212108 Dynamic TiBaseTalladium España, SL · 2021
- This deviceK221673 Bonafix TiBaseZentek Medical, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K251294Bonafix Implant AbutmentsZentek Medical, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −19 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −18 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −16 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −13 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −12 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −11 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −10 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −9 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −8 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −7 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −6 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −5 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −4 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −3 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −2 | K202026 | Blue Sky Bio CAD-CAM Abutments | Blue Sky Bio, LLC | 2020 | — |
| −1 | K212108 | Dynamic TiBase | Talladium España, SL | 2021 | — |
| 0 (this device) | K221673 | Bonafix TiBase | Zentek Medical, LLC | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 30.7 · 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 |
|---|---|---|---|
| * | K212108 | Dynamic TiBaseSummary page 4…ification Panel: Dental Products Panel Primary Product Code: NHA PREDICATE DEVICE INFORMATION Primary predicate K212108, Dynamic Ti-base. Talladium España, SL Zentek Medical LLC… | 2021 |
| † | K140934 | Hiossen Implant System | 2014 |
| † | K153758 | Straumann Bone Level Tapered Implants | 2016 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
| † | K142260 | NobelActive | 2015 |
| † | K153332 | ETIII SA Fixture System (O3.2mm) | 2016 |
| † | K193352 | AbutmentCAD | 2021 |
| † | K120243 | GAM-200 | 2012 |
| † | K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251294 | Bonafix Implant Abutments | 2025 | 0 |
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 27 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 44 of the 323 ancestors have a recall of any class.
- Of its descendants, K251294 (Zentek Medical, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K212108.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 TiBase 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 System | Implant Body Diameter (mm) | Implant Platform Diameter (mm) HIOSSEN ET III | 3.5 Mini | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular Nobel Active |3.5 NP | 4.3, 5.0 |RP Straumann Bone Level |3.3 NC | 4.1, 4.8 |RC Zimmer Screw-Vent/ |3.3…
Read the full statement (124 words)
Bonafix TiBase 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 System | Implant Body Diameter (mm) | Implant Platform Diameter (mm)
HIOSSEN ET III | 3.5 Mini
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular
Nobel Active |3.5 NP
| 4.3, 5.0 |RP
Straumann Bone Level |3.3 NC
| 4.1, 4.8 |RC
Zimmer Screw-Vent/ |3.3, 3.7, 4.1 13.5
Tapered Screw Vent |4.7 |4.5
| 6.0 15.7
Bonafix 2 Plus Implants | 3.5, 3.75, 4.20, 5.0, 6.0 |3.5
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/K221673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221673: Bonafix TiBase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221673
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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