# K180609: Rodo Smilekey

- Pathway: 510(k) (Traditional)
- Applicant: Rodo Medical, Inc.
- Decided: May 23, 2018 after 76 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894595 (1990). 152 ancestors in all.
No later device cites it as a predicate yet.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160786: RODO Abutment System, Rodo Medical, Inc. (2016) Summary page 4.

## Indications for use
The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.

Source page: https://510kreport.com/device/K180609
Methodology: https://510kreport.com/methodology