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 (Aka Osteon Medical) · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 5, 2022 as substantially equivalent to K212676 (Implant Solutions Pty Ltd (Osteon Medical), 2022) after a 90-day review. Its family tree reaches back 10 generations to 1995. 3 later devices descend from it.
- Decided
- Jul 5, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K944964 (1995). 65 ancestors in all, the oldest K871863 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations between
- 3 generations backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- 2 generations backK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- 1 generation backK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
- This deviceK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
- Descendant · cites it directly · 2 of its ownK233083 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024
- Descendant · 2 generations on · 1 of its ownK241032 BellaTek BarsBiomet 3i, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK260940 BellaTek BarsZimVie US Corp, LLC · 2026
Show all 10 generations
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 8 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 7 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 6 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 5 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 4 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 3 generations backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- 2 generations backK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- 1 generation backK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
- This deviceK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −9 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −6 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −5 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −4 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −3 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| −2 | K122424 | Isus Implant Suprastructures | Dentsply International, Inc. | 2013 | — |
| −1 | K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | 2022 | — |
| 0 (this device) | 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 | — |
| +2 | K241032 | BellaTek Bars | Biomet 3i, LLC | 2024 | — |
| +3 | 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 |
|---|---|---|
| 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 30.7 · 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 |
|---|---|---|---|
| * | K212676 | Osteon Precision Milled SuprastructureSummary page 5…ry, ENT and Dental Devices) Reviewing Division Division of Health Technology 1 B (Dental and ENT Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device • K212676, Osteon Precision Milled Suprastructure, Implant Solutions PTY LTD (aka Osteon Medical) Reference Device for OEM Compatib… | 2022 |
| † | K170588 | DESS Dental Smart Solutions | 2017 |
| † | K191986 | DESS Dental Smart Solutions | 2019 |
| † | K212628 | DESS Dental Smart Solutions | 2022 |
| † | K211109 | N1 TiUltra TCC Implant System | 2021 |
| † | K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | 2010 |
| † | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | 2006 |
| † | K961736 | 17 Angulated Abutment | 1996 |
| † | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | 2018 |
| † | K171757 | Straumann Screw Retained Abutments | 2017 |
| † | K192401 | Straumann Screw-Retained Abutments | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233083 | Osteon Precision Milled Suprastructure | 2024 | 2 |
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 7 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 65 ancestors have a recall of any class.
- Of its descendants, K233083 (Implant Solutions Pty Ltd (Aka Osteon Medical), 2024) has gone furthest, with 2 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. 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: • Astra Tech Implant System® Multi Base Abutment EV, 4.8…
Read the full statement (345 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:
• Astra Tech Implant System® Multi Base Abutment EV, 4.8 mm, max 30°
• DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
• 3i OSSEOTITE®
• Astra Tech OsseoSpeed™
• Neodent Grand Morse
• NobelReplace® Trilobe
• NobelReplace® Conical
• Nobel Brånemark System®
• Straumann BLX Implants
• DESS Dental Multi Unit Abutments, Angled, 3.4-6.5 mm, max 30°
• NobelActive® NobelParallel Conical
• Straumann® Bone Level
• Zimmer Screw Vent® and Tapered Screw-Vent®
• Dentium SuperLine® Abutments, 4.5-5.5 mm, max 30°
• Keystone Multi Unit Abutment, 4.8 mm, 0°
• Implant Direct GPS® Angled Abutment, 5.0 mm, max 30°
• MIS Multi-unit Abutments, 4.8 mm
• C1 Conical Connection Implant System, max 30°
• V3 Conical Connection Implant System, max 30°
• Internal Hex Implant System, max 30°
• Conical Connection, max 30°
• Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• Nobel Biocare Brånemark Multi Unit Abutment, 4.8 mm, max 17°
• Nobel Biocare Multi Unit Abutment Plus, 4.8 mm, max 30°
• Nobel Biocare Multi Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
• Nobel Biocare Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• Paltop Multi Unit Abutment, 5.0 mm, 0°
• Southern Compact Conical Abutments, 4.8 mm
• MAX Implant System, 0°
• Provata Implant System, max 30°
• Deep Conical (DC) Implants, 0°
• Piccolo Implants, 0°
• External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• Zimmer Angled Tapered Abutments, 4.5 mm, max 30°
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221019: Osteon Precision Milled Suprastructure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221019
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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