# K190508: EVO 450 series High Speed Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Ttbio Corp.
- Decided: Dec 11, 2019 after 285 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: 7 generations back to K935676 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141576: Maxima PRO 45L, Kavo DO Brasil Industria E Comercio Ltda (2015) Summary page 4.

## Indications for use
The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures.

Source page: https://510kreport.com/device/K190508
Methodology: https://510kreport.com/methodology