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Sterilizers Currently On Market That Manuafacturer Claims has FDA Clearance For Handpieces Sterilization (chart updated 10/98)

For the September 1998 issue of the Clinical Research Association newsletter, CRA called each of the sterilizer companies listed in the following chart to ask if they had FDA 510(k) numbers that included handpieces sterilization verification. FDA 510(k) numbers were then confirmed by FDA as of the chart's publication date of September 1998. For the full report, "JADA report Provokes Chemiclave Owners To Ask - Does Their Chemiclave Sterilize Handpieces?"", contact CRA; 3707 North Canyon Road, SAuite 6; Provo, UT 84604 or calkl at 801-226-2121 or visit CRA's website www.cranews.com. This chart had been posted with special permission from CRA.
Company Contacted by CRA Sterilizer Model Sterilizer Type FDA Cleared For Handpieces FDA Clearance # For
Handpiece Sterilization
Alfa Medical Cox 6000 Dry Heat YES K881371
Barnstead/Thermolyne Sterilmax Steam Heat YES K953938
Dentronix No FDA HP Clearance Dry Heat No No*
KaVo No FDA HP Clearance Steam Heat No No*
Midmark Corp No FDA HP Clearance Steam Heat No No*
Pelton & Crane Delta 8
Delta 10		 Steam Heat YES K945117
Porter Instruments Co SES 2012 Steam Heat YES K924596
SciCan Staim 900
Statim 2000
Statim 5000		 Steam Heat
Steam Heat
Steam Heat		 YES
YES
YES
 K944036
K915054
K962179
Steri Dent No FDA HP Clearance Dry Heat No No*
Tuttnauer No FDA HP Clearance Steam Heat No No*

* No means handpiece sterilization claims not made or could not be verified by FDA.

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