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Autoclave Sterilizer - Don't be affraid to make the right decision. 1-800-748-1259 |  |
| 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. |
| Sterilizers Currently On Market That Manuafacturer Claims Has FDA Clearance For Handpieces Sterilization (chart updated 10/98) |
| Company Contacted by CRA | Sterilizer Model | Sterilizer Type | FDA Cleared For Handpieces | FDA Clearance # For Handpiece Sterilization |
| 1. Alfa Medical | Cox 6000 | Dry Heat | YES | K881371 |
| 2. Barnstead/Thermolyne | Sterilmax | Steam Heat | YES | K953938 |
| 3. Dentronix | No FDA HP Clearance | Dry Heat | No | No* |
| 4. KaVo | No FDA HP Clearance | Steam Heat | No | No* |
| 5. Midmark Corp | No FDA HP Clearance | Steam Heat | No | No* |
| 6. Pelton & Crane | Delta 8 Delta 10 |
Steam Heat | YES | K945117 |
| 7. Porter Instruments Co | SES 2012 | Steam Heat | YES | K924596 |
| 8. SciCan | Staim 900 Statim 2000 Statim 5000 |
Steam Heat Steam Heat Steam Heat |
YES YES YES |
K944036 K915054 K962179 |
| 9. Steri Dent | No FDA HP Clearance | Dry Heat | No | No* |
| 10. Tuttnauer | No FDA HP Clearance | Steam Heat | No | No* |