# K973876: Prophyflex 2, Model 2012

- Pathway: 510(k) (Traditional)
- Applicant: Kavo America
- Decided: Dec 19, 1997 after 70 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.
26 later devices descend from it; 4 cite it directly.
0 of 27 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
- K991857: Airflow Handy (1999), 23 descendants of its own
- K022119: Ems Air-Flow Handy 2 Dental Handpiece (2002), 22 descendants of its own
- K092289: Ems Air-Flow Handy Perio (2009), 18 descendants of its own
- K110173: Ems Air-Flow Master Piezon (2011), 13 descendants of its own
- K190124: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (2019), 4 descendants of its own

## Indications for use
The PROPHYflex 2 dental device is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The product should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea.

Source page: https://510kreport.com/device/K973876
Methodology: https://510kreport.com/methodology