# K161639: Y-MIC

- Pathway: 510(k) (Traditional)
- Applicant: Micron Corporation
- Decided: Dec 22, 2016 after 191 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944714 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080089: Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument Tips, Sybron Dental Specialties, Inc. (2008) Summary page 4.

## Indications for use
The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.

Source page: https://510kreport.com/device/K161639
Methodology: https://510kreport.com/methodology