# K080761: Bonart's Arteotomy Omi and Opi Ultrasonic Surgery System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Bonart Co., Ltd.
- Decided: Aug 25, 2008 after 160 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ARTeotomy Ultrasonicsurgery system (OP1) uses piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal soft tissue trauma. The system is supplied with sharp, smoothing and blunt insert tips for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Piezo tips come in various shapes and forms (BS-OTi, BS-OT3, BS-OT5 etc.) and are designed to generate a vibrating frequency of 26-32 kHz The ARTeotomy Ultrasonic Surgery System (OMI) uses magnetostrictive ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The system is supplied with sharp, smoothing and blunt insert for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Inserts come in various shapes and forms (ART-AS, ART-LH, ART-L V eta) and are designed to generate a vibrating frequency of 24.5 kH7,

Source page: https://510kreport.com/device/K080761
Methodology: https://510kreport.com/methodology