510(k) · Cleared
ClearedBellaTek Bars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZimVie US Corp, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Sep 21, 2026 as substantially equivalent to K241032 (Biomet 3i, LLC, 2024) after a 185-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- Sep 21, 2026
- Review
- 185 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K944964 (1995). 68 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations between
- 3 generations backK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
- 2 generations backK233083 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024
- 1 generation backK241032 BellaTek BarsBiomet 3i, LLC · 2024
- This deviceK260940 BellaTek BarsZimVie US Corp, LLC · 2026
Show all 13 generations
- Root · 13 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 12 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 11 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 10 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 9 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 8 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 7 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 6 generations backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- 5 generations backK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- 4 generations backK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
- 3 generations backK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
- 2 generations backK233083 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024
- 1 generation backK241032 BellaTek BarsBiomet 3i, LLC · 2024
- This deviceK260940 BellaTek BarsZimVie US Corp, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −12 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −11 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −10 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −9 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −8 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −7 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −6 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| −5 | K122424 | Isus Implant Suprastructures | Dentsply International, Inc. | 2013 | — |
| −4 | K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | 2022 | — |
| −3 | K221019 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2022 | — |
| −2 | K233083 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2024 | — |
| −1 | K241032 | BellaTek Bars | Biomet 3i, LLC | 2024 | — |
| 0 (this device) | K260940 | BellaTek Bars | ZimVie US Corp, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K241032 | BellaTek BarsSummary page 6…ucts Panel implant abutment Reviewing Division: Division of Dental and ENT Devices Predicate Device Information Primary Predicate Device: • K241032 (SE 07/15/2024) – BellaTek Bars, ZimVie US Corp LLC (former Biomet 3i LLC) Reference Devices: • K170588 (SE… | 2024 |
| † | K170588 | DESS Dental Smart Solutions | 2017 |
| † | K191986 | DESS Dental Smart Solutions | 2019 |
| † | K212628 | DESS Dental Smart Solutions | 2022 |
| † | K222288 | DESS Dental Smart Solutions | 2022 |
| † | K231434 | DESS Dental Smart Solutions | 2023 |
| † | K240208 | DESS Dental Smart Solutions | 2024 |
| † | K252384 | DESS® Dental Smart Solutions | 2025 |
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 31 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 68 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
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?
The BellaTek Bars are indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments. All digitally designed BellaTek Bars are intended to be sent to ZimVie for manufacture. The BellaTek Bars are indicated for compatibility with the following abutment systems: DESS NobelActive®/…
Read the full statement (201 words)
The BellaTek Bars are indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments.
All digitally designed BellaTek Bars are intended to be sent to ZimVie for manufacture.
The BellaTek Bars are indicated for compatibility with the following abutment systems:
DESS NobelActive®/ NobelReplace® Multi-Unit Abutment Systems
DESS NobelActive®/ NobelReplace® MUA+ System
DESS Nobel Replace Select™ Multi-Unit Abutment Systems
DESS Nobel Brånemark Multi-Unit Abutment Systems
DESS ZimVie External Hex Multi-Unit Abutment Systems
DESS Straumann Bone Level Multi-Unit Abutment Systems
DESS Straumann Bone Level MUA+ System
DESS ZimVie Certain® Multi-Unit Abutment Systems
DESS Straumann BLX® Multi-Unit Abutment Systems
DESS Neodent Grand Morse (GM) Multi-Unit Abutment Systems
DESS Neodent Grand Morse (GM) MUA+ System
DESS ZimVie TSV® Multi-Unit Abutment Systems
DESS Astra Tech EV® Multi-Unit Abutment Systems
DESS Astra Tech Osseospeed Multi-Unit Abutment Systems
DESS Biohorizons Internal Hex Multi-Unit Abutment Systems
DESS Osstem® Multi-Unit Abutment Systems
DESS MIS Seven® Multi-Unit Abutment Systems
DESS Dentium Superline® & Implantium Multi-Unit Abutment Systems
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260940: BellaTek Bars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260940
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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