# K213139: SURGmatic S15 L Pro

- Pathway: 510(k) (Traditional)
- Applicant: Kavo Dental GmbH
- Decided: Dec 21, 2021 after 85 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, 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: 4 generations back to K002469 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140308: Mastersurg / Expertsurg, Kaltenbach & Voigt GmbH (2014) Summary page 4.

## Indications for use
The SURGmatic S15 L Pro handpiece is intended for: - Oral, jaw and facial surgery - Tooth extraction procedures - Root resection - Osteotomy - Removal of carious material - Tooth, cavity and crown preparations - Processing of fillings The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.

Source page: https://510kreport.com/device/K213139
Methodology: https://510kreport.com/methodology