510(k) · Cleared
ClearedBellaTek Bars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 15, 2024 as substantially equivalent to K233083 (Implant Solutions Pty Ltd (Aka Osteon Medical), 2024) after a 90-day review. Its family tree reaches back 12 generations to 1995. 1 later device descends from it.
- Decided
- Jul 15, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K944964 (1995). 67 ancestors in all, the oldest K871863 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations between
- 3 generations backK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
- 2 generations backK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
- 1 generation backK233083 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024
- This deviceK241032 BellaTek BarsBiomet 3i, LLC · 2024
- Descendant · cites it directly · 0 of its ownK260940 BellaTek BarsZimVie US Corp, LLC · 2026
Show all 12 generations
- Root · 12 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 11 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 10 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 9 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 8 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 7 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 6 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 5 generations backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- 4 generations backK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- 3 generations backK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
- 2 generations backK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
- 1 generation backK233083 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024
- This deviceK241032 BellaTek BarsBiomet 3i, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K260940BellaTek BarsZimVie US Corp, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −11 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −10 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −9 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −8 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −7 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −6 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −5 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| −4 | K122424 | Isus Implant Suprastructures | Dentsply International, Inc. | 2013 | — |
| −3 | K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | 2022 | — |
| −2 | K221019 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2022 | — |
| −1 | K233083 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2024 | — |
| 0 (this device) | K241032 | BellaTek Bars | Biomet 3i, LLC | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K233083 | Osteon Precision Milled SuprastructureSummary page 5…Endosseous dental implant abutment Classification Number: Class II (21 CFR 872.3630) Primary Product Code: NHA Predicate Devices Primary Predicate Device: K233083, Osteon Precision Milled Suprastructure, March 9, 2024 Reference Predicate Device: K080864, Biomet 3i CAM StructSURE® Precision… | 2024 |
| † | K080864 | Cam Structsure Precision Milled Bars | 2008 |
| † | K180998 | BioHorizons CAD/CAM Bars | 2018 |
| † | K231434 | DESS Dental Smart Solutions | 2023 |
| † | K092341 | Low Profile Abutments - Internal and External Connection | 2009 |
| † | K111853 | Angled Tapered Abutment | 2011 |
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 |
|---|---|---|---|
| K260940 | BellaTek Bars | 2026 | 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 29 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 67 ancestors have a recall of any class.
- Of its descendants, K260940 (ZimVie US Corp, LLC, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Biomet 3i for manufacture. The BellaTek Bars are indicated for compatibility with the following abutment systems: * Universal Multi-Unit…
Read the full statement (139 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 Biomet 3i for manufacture.
The BellaTek Bars are indicated for compatibility with the following abutment systems:
* Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 30 degrees
* ZimVie Eztetic Implant System
* ZimVie TSX Implant System
* ZimVie Tapered Screw-Vent System
* ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30 degrees
* ZimVie Osseotite Implant System
* ZimVie T3 and T3 PRO Implant System
* ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 30 degrees
* ZimVie TSX Implant System
* ZimVie Tapered Screw-Vent Implant System
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241032: 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/K241032
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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