# K140736: Sterisafe HP Table-Top Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Milton E Pedrazzi D.D.S., Inc.
- Decided: Jan 20, 2015 after 302 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The SteriSafe HP Table-Top Steam Sterilizer is designed to sterilize and flush dental handpieces in a clinical setting. It uses saturated steam at high pressure to effectively kill microorganisms. The unit is intended to sterilize and flush moisture stable handpieces. The handpieces must be suitable for steam %terilization up to 135°C (275°F). The sterilization cycle is as follows: CYCLE TEMPERATURE STERILIZATION TIME / LOAD INTENDED USE TURNAROUND TIME Unwrapped Sterilization 10 minutes / 23 minutes Maximum Load Sterilize & Flush Temperature 132°C is 3 Handpieces Dental Handpieces Sterilization Maximum Load Temperature Control Weight is 150z 132°C <0° to +3°C

Source page: https://510kreport.com/device/K140736
Methodology: https://510kreport.com/methodology