The following data is part of a premarket notification filed by Periogiene with the FDA for Odontosurge 2.
| Device ID | K981390 |
| 510k Number | K981390 |
| Device Name: | ODONTOSURGE 2 |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | PERIOGIENE 15825 SHADY GROVE RD. SUITE 90 Rockville, MD 20850 |
| Contact | David L West |
| Correspondent | David L West PERIOGIENE 15825 SHADY GROVE RD. SUITE 90 Rockville, MD 20850 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-16 |
| Decision Date | 1998-06-11 |
| Summary: | summary |