# K071965: I-Surge

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Sep 10, 2007 after 56 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- 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
Longest line of descent: 1 generation back to K000049 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000049: Suni Max, Satelec (2000) Summary page 1.

## Indications for use
The Satelec i-Surge is intended to be used by qualified dental practitioners as an electric micro-motor handpiece with a straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance.

Source page: https://510kreport.com/device/K071965
Methodology: https://510kreport.com/methodology