DENTRONIX MODEL 2000
FDA 510(k) clearance K910202 · decided 1991-03-13
Clearance details
- K-number
- K910202
- Device name
- DENTRONIX MODEL 2000
- Applicant
- Dentronix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-10
- Decision date
- 1991-03-13
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- KMH
- Device class
- 2
- Regulation number
- 880.6870
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ivyland, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STERI-DENT, STERI-SURE (K094026) | Cpac, Inc. | 2011-07-12 |
| DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (K051660) | Coltene/Whaledent, Inc. | 2005-08-04 |
| DISINFECTION WITH THE COX DRY HEAT STERILIZER (K910925) | Cox Sterile Products, Inc. | 1992-05-08 |
| DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (K880322) | Dentronix, Inc. | 1988-07-13 |
| COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE (K881371) | Cox Sterile Products, Inc. | 1988-04-13 |
| COX RAPID HEAT TRANSFER STERILIZER (K872643) | Cox Sterile Products, Inc. | 1987-10-29 |
| U. V. GERMICIDAL UNIT (K871615) | Lorvic Corp. | 1987-09-11 |
| INOX DRY HEAT STERILIZER (K851307) | Broadwest Corp. | 1985-05-09 |
| DRY HEAT STERILIZER (K771070) | Cpac, Inc. | 1977-07-14 |
Recalls involving this device
No recalls on record reference this clearance.