# K081811: CARE3 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jan 21, 2009 after 209 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171553: W&H Assistina Twin (2017), 0 descendants of its own

## Indications for use
Care3 Plus is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments NOTE Care3 Plus should be used with only pre-cleaned dental handpieces and before they are sterilized Nakaiishi proposes that Care3 Plus carry the following label CAUTION Federal (US) law restricts the use of this device to licensed professionals

Source page: https://510kreport.com/device/K081811
Methodology: https://510kreport.com/methodology