# K994298: Frios Microsaw

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Feb 18, 2000 after 59 days
- Product code: KMW (Handpiece, Rotary Bone Cutting)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971692 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971692: Osteopower System and Accessories, Osteomed Corp. (1997) Summary page 1.

## Indications for use
The FRIOS MicroSaw is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.

Source page: https://510kreport.com/device/K994298
Methodology: https://510kreport.com/methodology