Product code KMH
- Device name
- Sterilizer, Dry Heat
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6870
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K094026 | STERI-DENT, STERI-SURE | Cpac, Inc. | 2011-07-12 |
| K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | Coltene/Whaledent, Inc. | 2005-08-04 |
| K910925 | DISINFECTION WITH THE COX DRY HEAT STERILIZER | Cox Sterile Products, Inc. | 1992-05-08 |
| K910202 | DENTRONIX MODEL 2000 | Dentronix, Inc. | 1991-03-13 |
| K880322 | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | Dentronix, Inc. | 1988-07-13 |
| K881371 | COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE | Cox Sterile Products, Inc. | 1988-04-13 |
| K872643 | COX RAPID HEAT TRANSFER STERILIZER | Cox Sterile Products, Inc. | 1987-10-29 |
| K871615 | U. V. GERMICIDAL UNIT | Lorvic Corp. | 1987-09-11 |
| K851307 | INOX DRY HEAT STERILIZER | Broadwest Corp. | 1985-05-09 |
| K771070 | DRY HEAT STERILIZER | Cpac, Inc. | 1977-07-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B234KMHRHPRO9115V4 | RH-Pro9-230V | CPAC EQUIPMENT, INC. | 2020-10-01 |
| B234KMHRHPRO9115V3 | RH-Pro9 | CPAC EQUIPMENT, INC. | 2020-10-01 |
| B234KMHRHPRO111230V1 | RH-Pro11-230V | CPAC EQUIPMENT, INC. | 2020-10-01 |
| M36883761 | GRAFCO | GF HEALTH PRODUCTS, INC. | 2020-08-24 |
| M36883751 | GRAFCO | GF HEALTH PRODUCTS, INC. | 2020-08-24 |
| B234KMHRHPRO111115V0 | RH-Pro11 | CPAC EQUIPMENT, INC. | 2019-01-18 |
| B234KMHSD301000230 | STERIDENT | CPAC EQUIPMENT, INC. | 2018-08-31 |
| B234KMHSD301000115 | STERIDENT | CPAC EQUIPMENT, INC. | 2018-08-31 |
| B234KMHSD201000230 | STERIDENT | CPAC EQUIPMENT, INC. | 2018-08-31 |
| B234KMHSD201000115 | STERIDENT | CPAC EQUIPMENT, INC. | 2018-08-31 |
| B234KMHSS2100230V0 | STERISURE | CPAC EQUIPMENT, INC. | 2018-08-24 |
| B234KMHSS2100115V2 | STERISURE | CPAC EQUIPMENT, INC. | 2018-08-24 |
| B234KMHCX6220230V163 | COX RAPIDHEAT | CPAC EQUIPMENT, INC. | 2018-08-24 |
| B234KMHCX6220230V152 | COX RAPIDHEAT | CPAC EQUIPMENT, INC. | 2018-08-24 |
| B234KMHCX6000115V161 | COX RAPIDHEAT | CPAC EQUIPMENT, INC. | 2018-08-23 |
| B234KMHCX6000115V150 | COX RAPIDHEAT | CPAC EQUIPMENT, INC. | 2018-07-31 |
| D661DSSH10 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661DDS7000230K0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661DDS70002300 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661DDS70001150 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661DADUL0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661DADBL0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661D7107010 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661D7000SILVER0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661D7000MS0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661D7000F0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661D7000CL0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661D7000C0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661D5000ST0 | Dentronix | DENTRONIX INC | 2016-07-15 |
| D661D5000SHT0 | Dentronix | DENTRONIX INC | 2016-07-15 |