# K242703: LW Pre-milled Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Ossvis Co., Ltd.
- Decided: Dec 5, 2024 after 87 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: 16 generations back to K894844 (1990). 219 ancestors in all.
No later device cites it as a predicate yet.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210362: s-Clean Pre-Milled Abutment, Dentis Co., Ltd. (2021) Summary page 5.

## Indications for use
LW Pre-milled Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or filly edentulous patient. LW Pre-milled Abutment is intended for use with the LW Implant System in the chart. All digitally designed abutments for use with LW Pre-milled Abutment are intended to be manufactured at the OSSVIS-validated milling center.

Source page: https://510kreport.com/device/K242703
Methodology: https://510kreport.com/methodology