# K241616: ALLONUS Tech Prosthetics

- Pathway: 510(k) (Traditional)
- Applicant: Allonus Tech Co., Ltd.
- Decided: Dec 17, 2024 after 195 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: 14 generations back to K894844 (1990). 196 ancestors in all.
No later device cites it as a predicate yet.
0 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 5.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 6.
- K171142: Healing Cap Multi-Unit Titanium, Nobel Biocare AB (2017) Summary page 6.
- K123988: Anyonetm Internal Implant System, Megagen Implant Co., Ltd. (2013) Summary page 6.

## Indications for use
ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations. It is compatible with the following systems: • Astra OsseoSpeed EV(K130999) 3.0 • Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm • Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm • BioHorizons Laser-Lok Implant System (K093321) 3.0 mm • Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm • Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini, Regular) • Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1) • Neodent Implant System - GM Helix (K163194, Kl80536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) • Nobel Active 3.0 (K102436) 3.0 • Nobel Active Internal Connection Implant (K071370) NP RP • Nobelactive Wide Platform (Wp) (K133731) WP • Straumann BLX Implant (Kl73961, Kl81703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB) • Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (Kl62890) 2.9 (SC) • Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC) • Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9) • (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7) All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

Source page: https://510kreport.com/device/K241616
Methodology: https://510kreport.com/methodology