510(k) · Cleared
ClearedOsteon Precision Milled Suprastructure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Solutions Pty Ltd (Osteon Medical) · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 3, 2022 as substantially equivalent to K122424 (Dentsply International, Inc., 2013) after a 191-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 3, 2022
- Review
- 191 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K944964 (1995). 64 ancestors in all, the oldest K871863 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 2 generations backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- 1 generation backK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- This deviceK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
- Descendant · cites it directly · 3 of its ownK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
- Descendant · 2 generations on · 2 of its ownK233083 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024
- Descendant · 3 generations on · 1 of its ownK241032 BellaTek BarsBiomet 3i, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK260940 BellaTek BarsZimVie US Corp, LLC · 2026
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 3 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 2 generations backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- 1 generation backK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- This deviceK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
Most influential descendants
Showing 4 of 4 · See all- K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022 · cites it directly3descendants
- K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024 · 2 generations on2descendants
- K241032BellaTek BarsBiomet 3i, LLC · 2024 · 3 generations on1descendant
- K260940BellaTek BarsZimVie US Corp, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −3 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −2 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| −1 | K122424 | Isus Implant Suprastructures | Dentsply International, Inc. | 2013 | — |
| 0 (this device) | K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | 2022 | — |
| +1 | 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 | — |
| +3 | K241032 | BellaTek Bars | Biomet 3i, LLC | 2024 | — |
| +4 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K122424 | Isus Implant SuprastructuresSummary page 4…Product Code: NHA 3. Information for the 510(k) Cleared Device (Predicate Device): Primary Predicate: ISUS Implant Suprastructures (K122424) Reference Device: Panthera Dental Milled Bars (K173466) Reference Devices for OEM Compatibili… | 2013 |
| † | K173466 | Panthera Dental Milled Bars | 2018 |
| † | K161416 | Multi-unit Abutment Plus | 2017 |
| † | K202344 | TiUltra Implants and Xeal Abutments | 2020 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
| † | K112162 | Conical Connection Implants | 2012 |
| † | K180282 | MIS Internal Hex Dental Implant System | 2018 |
| † | K191054 | Southern Implants MAX Implant System | 2019 |
| † | K180465 | Provata Implant System | 2018 |
| † | K163060 | Deep Conical (DC) Implants and Accessories | 2017 |
| † | K173706 | Piccolo Implants and Accessories | 2018 |
| † | K163634 | External Hex Implants | 2017 |
| † | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | 2017 |
| † | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection… | 2005 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K153509 | GPS Angled Abutment | 2016 |
| † | K141457 | Dentium Implantium and Superline Abutments | 2014 |
| † | K111853 | Angled Tapered Abutment | 2011 |
| † | K112795 | Paltop Dental Implant System | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221019 | Osteon Precision Milled Suprastructure | 2022 | 3 |
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 6 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 64 ancestors have a recall of any class.
- Of its descendants, K221019 (Implant Solutions Pty Ltd (Aka Osteon Medical), 2022) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K122424.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments. The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems: • Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°…
Read the full statement (210 words)
The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
• Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
• Nobel Biocare Xeal Abutments, 4.8mm, max 30°
• Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
• MIS Multi-unit Abutments, 4.8mm
• C1 Conical Connection Implant System, max 30°
• V3 Conical Connection Implant System, max 30°
• Internal Hex Implant System, max 30°
• Conical Connection, max 30°
• Southern Compact Conical Abutments, 4.8mm
• MAX Implant System, 0°
• Provata Implant System, max 30°
• Deep Conical (DC) Implants, 0°
• Piccolo Implants, 0°
• External Hex Implants, max 30°
• Astra Tech lmplant System® Multi Base Abutment EV, 4.8mm, max 30°
• Keystone Multi Unit Abutment, 4.8mm, 0°
• Neodent GM Mini Conical Abutment, 4.8mm, max 30°
• lmplant Direct GPS® Angled Abutment, 5.0mm, max 30°
• Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
• Zimmer Angled Tapered Abutments, 4.5mm, max 30°
• Paltop Multi Unit Abutment, 5.0mm, max 17°
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212676: Osteon Precision Milled Suprastructure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212676
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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