The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Odyssey 2.4g, Denlaser Elite, Model 002-00050.
| Device ID | K050453 |
| 510k Number | K050453 |
| Device Name: | ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Harnett |
| Correspondent | Donna Harnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-05-27 |
| Summary: | summary |