The following data is part of a premarket notification filed by Dentronix Inc. with the FDA for Dentronix Model 2000.
| Device ID | K910202 |
| 510k Number | K910202 |
| Device Name: | DENTRONIX MODEL 2000 |
| Classification | Sterilizer, Dry Heat |
| Applicant | DENTRONIX INC. 101 STEAMWHISTLE DR. Ivyland, PA 18974 |
| Contact | David Hamlin |
| Correspondent | David Hamlin 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 | 1991-01-10 |
| Decision Date | 1991-03-13 |