Search Results
Found 1 results
510(k) Data Aggregation
K Number
K052532Device Name
IMAX 9.5 STERILIZERS
Manufacturer
Date Cleared
2006-09-05
(355 days)
Product Code
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
DENTAL X SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities.
Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below).
| Cycle | Temperature<br>(°C) | Pressure<br>(bar) | Exposure<br>Time (min.) | Drying Time<br>(min.) | Maximum<br>Load (kg) |
|---------------------------|---------------------|-------------------|-------------------------|-----------------------|----------------------|
| Unwrapped<br>instruments* | 134 | 2.14 – 2.21 | 4 | 6 | 4.0 |
| Wrapped<br>instruments** | 134 | 2.14 – 2.21 | 20 | 20 | 4.0 |
| Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 |
* Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.)
** Dental handpieces can be processed in the Wrapped instruments cycle only
The sterilizer is not intended to sterilize patient-contacting liquids.
Device Description
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer. The iMax 9.5 DS Sterilizer is provided with a diaphragm compressor and HEPA filter that circulates filtered air in the sterilization chamber during the drying phase.
Ask a Question
Ask a specific question about this device
Page 1 of 1