# K100785: Bonart Model Art-IM1 Implantor System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Bonart Co., Ltd.
- Decided: Dec 3, 2010 after 259 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 ART-IMi1 Implantor is an implant machine system. it is primarily used by dental professionals in doing oral implant surgery or implantology such as drilling, reaming, cutting, etc. This system is also used for fixing previous broken or failed implant procedure.

Source page: https://510kreport.com/device/K100785
Methodology: https://510kreport.com/methodology