# K024133: CLS-2000 Unit

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Oct 1, 2003 after 289 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- 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 K936181 (1994). 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)
- K992744: Midmark M4*9 Easyclave Steam Sterilizer, Midmark Corp. (2000) Summary page 1.

## Indications for use
Rinse, flush, lubricate and steam sterilize dental handpieces, air-motors, and attachments which are suitable for steam sterilization Rinse and steam sterilize dental instruments which are suitable for steam sterilization Steam sterilization at 134°C and 3.1 bar absolute for ten minutes Maximum load is six (6) dental handpieces (highspeed handpieces, air-motors, and/or attachments) or five (5) dental instruments Sterility of devices is compromised on exposure to a non-sterile environment

Source page: https://510kreport.com/device/K024133
Methodology: https://510kreport.com/methodology