# K163239: SMARTmatic

- Pathway: 510(k) (Traditional)
- Applicant: Kaltenbach & Voigt GmbH
- Decided: Mar 17, 2017 after 119 days
- Product code: EFA (Handpiece, Belt And/Or Gear Driven, 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: 2 generations back to K070663 (2007). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143465: MASTERmatic LUX, Kaltenbach & Voigt GmbH (2015) Summary page 4.

## Most influential descendants
- K192809: Dental Handpiece (2020), 2 descendants of its own
- K220577: Dental Handpiece, Model CA160, CA160L, and CA500L (2022), 1 descendant of its own
- K232810: Dental Handpiece, Wireless Endodontic Handpiece, endoit (2023), 0 descendants of its own

## Indications for use
The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K163239
Methodology: https://510kreport.com/methodology