The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Dentronix Dds 7000 Rapid Dry Heat Sterilizer Sterilization System.
| Device ID | K051660 |
| 510k Number | K051660 |
| Device Name: | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM |
| Classification | Sterilizer, Dry Heat |
| Applicant | COLTENE/WHALEDENT INC. 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223 |
| Contact | Loretta Mooney |
| Correspondent | Loretta Mooney COLTENE/WHALEDENT INC. 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223 |
| Product Code | KMH |
| CFR Regulation Number | 880.6870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-22 |
| Decision Date | 2005-08-04 |
| Summary: | summary |