# K243731: HEXIM Implant; Samwon General Abutments

- Pathway: 510(k) (Traditional)
- Applicant: P&A USA
- Decided: Jul 9, 2025 after 217 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K894595 (1990). 265 ancestors in all.
No later device cites it as a predicate yet.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111889: Zimmer Dental Tapered Screw-Vent M Implant, Zimmer Dental, Inc. (2011) Summary page 5.
- K221866: S-Plant Dental Implant System, Newton Implant Systems, Inc. (2024) Summary page 5.

## Indications for use
The Hexim Implant - The HEXIM Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The HEXIM Implant System is for two stage surgical procedures. It is intended for delayed loading. Samwon General Abutments - Couple Abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

Source page: https://510kreport.com/device/K243731
Methodology: https://510kreport.com/methodology