# K213428: EdgePro

- Pathway: 510(k) (Special)
- Applicant: Biolase, Inc.
- Decided: Dec 22, 2021 after 62 days
- Product code: NVK (Laser, Dental, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K910422 (1992). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161669: Waterlase Express, Biolase, Inc. (2016) Summary page 4.

## Indications for use
Root Canal Hard Tissue Indications (for use on adult and pediatric patients) - Root canal preparation including enlargement - Root canal debridement and cleaning Root Canal Disinfection (for use on adult and pediatric patients) - Laser root canal disinfection after endodontic treatment

Source page: https://510kreport.com/device/K213428
Methodology: https://510kreport.com/methodology