K910202 is an FDA 510(k) clearance for the DENTRONIX MODEL 2000. This device is classified as a Sterilizer, Dry Heat (Class II - Special Controls, product code KMH).
Submitted by Dentronix, Inc. (Ivyland, US). The FDA issued a Cleared decision on March 13, 1991, 62 days after receiving the submission on January 10, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6870.
| 510(k) Number | K910202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1991 |
| Decision Date | March 13, 1991 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KMH — Sterilizer, Dry Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6870 |