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510(k) Data Aggregation
K Number
K140736Device Name
STERISAFE HP TABLE-TOP STEAM STERILIZER
Manufacturer
Date Cleared
2015-01-20
(302 days)
Product Code
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
MILTON E PEDRAZZI D.D.S., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 must be suitable for steam sterilization up to 135°C (275°F). The sterilization cycle is as follows:
| CYCLE | TEMPERATURE | STERILIZATION TIME<br>TURNAROUND TIME | LOAD | INTENDED USE |
|-----------|-----------------------------------------------------------|---------------------------------------|---------------------------------|----------------------------------------|
| Unwrapped | Sterilization<br>Temperature 132°C | 10 minutes / 23 minutes | Maximum Load<br>is 3 Handpieces | Sterilize & Flush<br>Dental Handpieces |
| | Sterilization<br>Temperature Control<br>132°C =0° to +3°C | | Maximum Load<br>Weight is 150z | |
Device Description
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