The following data is part of a premarket notification filed by Odonto-wave with the FDA for Odontosurge 3.
| Device ID | K001560 |
| 510k Number | K001560 |
| Device Name: | ODONTOSURGE 3 |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | ODONTO-WAVE 1136 EAST STUART, #4207 Fort Collins, CO 80525 |
| Contact | James Dieroff |
| Correspondent | James Dieroff ODONTO-WAVE 1136 EAST STUART, #4207 Fort Collins, CO 80525 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-08-24 |