# K141576: Maxima PRO 45L

- Pathway: 510(k) (Traditional)
- Applicant: Kavo DO Brasil Industria E Comercio Ltda
- Decided: May 4, 2015 after 326 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: 6 generations back to K935676 (1995). 12 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112024: TI-Max X450, Nakanishi, Inc. (2012) Summary page 5.
- K101717: Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H Coupling, Aerobine, Inc. (2010) Summary page 5.

## Most influential descendants
- K221741: TRAUS Air Dental Handpiece (2023), 0 descendants of its own
- K202371: Highspeed Airturbine Handpiece (2021), 0 descendants of its own
- K190508: EVO 450 series High Speed Handpieces (2019), 0 descendants of its own

## Indications for use
This air-powered dental handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K141576
Methodology: https://510kreport.com/methodology