The following data is part of a premarket notification filed by Dentronix Inc. with the FDA for Dentronix Dds 5000 Dry Heat Sterilization System.
| Device ID | K880322 |
| 510k Number | K880322 |
| Device Name: | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM |
| Classification | Sterilizer, Dry Heat |
| Applicant | DENTRONIX INC. 101 STEAMWHISTLE DR. Ivyland, PA 18974 |
| Contact | Peter O Sildve |
| Correspondent | Peter O Sildve DENTRONIX INC. 101 STEAMWHISTLE DR. Ivyland, PA 18974 |
| Product Code | KMH |
| CFR Regulation Number | 880.6870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-27 |
| Decision Date | 1988-07-13 |