# K171872: P50 Series Dental Operative Unit and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Pelton & Crane
- Decided: Apr 26, 2018 after 307 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962071 (1996). 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)
- K161488: ESTETICA Dental Treatment Unit and Accessories, Kaltenbach & Voigt GmbH (2016) Summary page 4.

## Indications for use
The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.

Source page: https://510kreport.com/device/K171872
Methodology: https://510kreport.com/methodology