# K221019: Osteon Precision Milled Suprastructure

- Pathway: 510(k) (Traditional)
- Applicant: Implant Solutions Pty Ltd (Aka Osteon Medical)
- Decided: Jul 5, 2022 after 90 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K944964 (1995). 65 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212676: Osteon Precision Milled Suprastructure, Implant Solutions Pty Ltd (Osteon Medical) (2022) Summary page 5.

## Most influential descendants
- K233083: Osteon Precision Milled Suprastructure (2024), 2 descendants of its own
- K241032: BellaTek Bars (2024), 1 descendant of its own
- K260940: BellaTek Bars (2026), 0 descendants of its own

## Indications for use
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°

Source page: https://510kreport.com/device/K221019
Methodology: https://510kreport.com/methodology