# K981390: Odontosurge 2

- Pathway: 510(k) (Traditional)
- Applicant: Periogiene
- Decided: Jun 11, 1998 after 56 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943450 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962445: Arthrocare Dental Electrosurgery System, Arthrocare Corp. (1996) Summary page 1.

## Indications for use
The ODONTOSURGE 2 is intended for use in removing soft tissue and controlling bleeding in the oral cavity during surgical procedures in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.

Source page: https://510kreport.com/device/K981390
Methodology: https://510kreport.com/methodology