KMH · Sterilizer, Dry Heat
General Hospital · 21 CFR 880.6870 · Class 2
Overview
| Product Code | KMH |
|---|---|
| Device Name | Sterilizer, Dry Heat |
| Regulation | 21 CFR 880.6870 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K094026 | STERI-DENT, STERI-SURE | Cpac, Inc. | Jul 12, 2011 | SESE |
| K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | Coltene/Whaledent, Inc. | Aug 4, 2005 | SESE |
| K910925 | DISINFECTION WITH THE COX DRY HEAT STERILIZER | Cox Sterile Products, Inc. | May 8, 1992 | SESE |
| K910202 | DENTRONIX MODEL 2000 | Dentronix, Inc. | Mar 13, 1991 | SESE |
| K880322 | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | Dentronix, Inc. | Jul 13, 1988 | SESE |
| K881371 | COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE | Cox Sterile Products, Inc. | Apr 13, 1988 | SESE |
| K872643 | COX RAPID HEAT TRANSFER STERILIZER | Cox Sterile Products, Inc. | Oct 29, 1987 | SESE |
| K871615 | U. V. GERMICIDAL UNIT | Lorvic Corp. | Sep 11, 1987 | SESE |
| K851307 | INOX DRY HEAT STERILIZER | Broadwest Corp. | May 9, 1985 | SESE |
| K771070 | DRY HEAT STERILIZER | Cpac, Inc. | Jul 14, 1977 | SESE |
Top Applicants
- Cox Sterile Products, Inc. — 3 clearances
- Cpac, Inc. — 2 clearances
- Dentronix, Inc. — 2 clearances
- Broadwest Corp. — 1 clearance
- Coltene/Whaledent, Inc. — 1 clearance
