# K232383: iPhysio® System

- Pathway: 510(k) (Traditional)
- Applicant: Euroteknika
- Decided: Mar 4, 2025 after 574 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: 19 generations back to K960026 (1996). 412 ancestors in all.
No later device cites it as a predicate yet.
0 of 413 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192893: Straumann Ceramic Healing Abutments, Institut Straumann AG (2020) Summary page 6.
- K220022: TRATE Dental Implant System, Trate AG (2022) Summary page 6.
- K173374: TSV BellaTek Encode Healing Abutments, Biomet 3i (2017) Summary page 6.
- K212628: DESS Dental Smart Solutions, Terrats Medical SL (2022) Summary page 6.
- K231803: Neodent Implant System - Zirconia Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A. (2023). Cleared while this submission was under review Summary page 6.
- K220200: Paltop Conical Implant System, Paltop Advanced Dental Solutions, Ltd. (2022) Summary page 6.

## Indications for use
Indications for Use for iPhysio® Profile Designer: iPhysio® System Profile Designers are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with compatible implant connections. The healing abutments are intended for use up to 6 months. Indications for Use for iPhysio® PEEK Temporary Abutment: The iPhysio® System PEEK Temporary Abutment is an abutment placed on the iPhysio® System Profile Designer to provide support for prosthetic structures for up to 6 months. It can be used in single- or two-stage procedures and is intended to be placed out of occlusion.

Source page: https://510kreport.com/device/K232383
Methodology: https://510kreport.com/methodology