510(k) · Cleared
ClearedOmni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Denture Conversions, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 11, 2026 as substantially equivalent to K242064 (Smart Denture Conversions, LLC, 2025) and 4 other predicates after a 171-day review. Its family tree reaches back 18 generations to 1996.
- Decided
- Jun 11, 2026
- Review
- 171 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K960026 (1996). 415 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK233316 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- 1 generation backK240208 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- This deviceK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 8 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 7 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 6 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 5 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 4 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK233316 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- 1 generation backK240208 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- This deviceK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −8 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −7 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −6 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −5 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −4 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −2 | K233316 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 | — |
| −1 | K240208 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 | — |
| 0 (this device) | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
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 | 8 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 16 | 0 |
| 1994 | 13 | 0 |
| 1995 | 20 | 0 |
| 1996 | 17 | 0 |
| 1997 | 10 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 21 | 0 |
| 2002 | 22 | 0 |
| 2003 | 18 | 0 |
| 2004 | 20 | 0 |
| 2005 | 16 | 0 |
| 2006 | 26 | 0 |
| 2007 | 38 | 0 |
| 2008 | 20 | 0 |
| 2009 | 15 | 0 |
| 2010 | 14 | 0 |
| 2011 | 19 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 30.6 · 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? (5)
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 |
|---|---|---|---|
| * | K242064 | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Summary page 6…Division of Dental and ENT Devices 510(k) Type: Abbreviated 510(k) PREDICATE AND REFERENCE DEVICE INFORMATION Primary Predicate: K242064, Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™), Smart Denture Conversions, LLC Reference Devices: K240208, D… | 2025 |
| * | K240208 | DESS Dental Smart SolutionsSummary page 6…ENCE DEVICE INFORMATION Primary Predicate: K242064, Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™), Smart Denture Conversions, LLC Reference Devices: K240208, DESS Dental Smart Solutions, Terrats Medical SL K232418, Single Platform SP1 Implant Solution, Southern Implants Ltd K180465, Pr… | 2024 |
| * | K232418 | Single Platform SP1 Implant SystemSummary page 6…Directional Multi-unit Abutment System (Trade Name: Omnibut™), Smart Denture Conversions, LLC Reference Devices: K240208, DESS Dental Smart Solutions, Terrats Medical SL K232418, Single Platform SP1 Implant Solution, Southern Implants Ltd K180465, Provata Implant System, Southern Implants Ltd K213576, Tatu… | 2023 |
| * | K180465 | Provata Implant SystemSummary page 6…Denture Conversions, LLC Reference Devices: K240208, DESS Dental Smart Solutions, Terrats Medical SL K232418, Single Platform SP1 Implant Solution, Southern Implants Ltd K180465, Provata Implant System, Southern Implants Ltd K213576, Tatum Surgical Dental Implant System, Tatum Surgical Reference Devices fo… | 2018 |
| * | K213576 | Tatum Surgical Dental Implant SystemSummary page 6…SS Dental Smart Solutions, Terrats Medical SL K232418, Single Platform SP1 Implant Solution, Southern Implants Ltd K180465, Provata Implant System, Southern Implants Ltd K213576, Tatum Surgical Dental Implant System, Tatum Surgical Reference Devices for OEM Implant Body Clearances: K163194, Neodent Implant… | 2022 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K201225 | Neodent Implant System - GM Helix Implants 7.0 | 2020 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K083205 | Nobelactive 8.5 MM & 18.0 MM | 2009 |
| † | K142260 | NobelActive | 2015 |
| † | K161416 | Multi-unit Abutment Plus | 2017 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | 2018 |
| † | K191256 | Straumann BLX Ø3.5 mm Implants | 2019 |
| † | K210855 | Straumann BLX Implant System | 2021 |
| † | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | 2022 |
| † | K230108 | Straumann® BLC and TLC Implants | 2023 |
| † | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11… | 2007 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K103691 | Biohorizons Abutments for Zimmer | 2011 |
| † | K121787 | Biohorizons Tapered Internal Plus Implants | 2012 |
| † | K172576 | BioHorizons Tapered Short Implants | 2017 |
| † | K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | 2023 |
| † | K140091 | Xpeed Anyridge Internal Implant Sysyem | 2014 |
| † | K122231 | Xpeed Any Ridge Internal Implant System | 2012 |
| † | K140934 | Hiossen Implant System | 2014 |
| † | K222636 | ET Abutment System | 2023 |
| † | K191054 | Southern Implants MAX Implant System | 2019 |
| † | K222457 | Provata Implant System | 2023 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K240187 | Tapered Pro Conical Implant System | 2024 |
| † | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua… | 2014 |
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 8 companies; a new generation was cleared every 10 months on median.
- 55 of the 415 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. 2026, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2007high 51 (2023) · low 19 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
2007high 211 (2021) · low 90 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
2007high 36 (2016) · low 0 (2009)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
2007high 858 (2015) · low 1 (2007)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?
The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254145
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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