The following data is part of a premarket notification filed by Oratronics, Inc. with the FDA for Oratronics Endosseous Frame Assembly.
| Device ID | K791366 |
| 510k Number | K791366 |
| Device Name: | ORATRONICS ENDOSSEOUS FRAME ASSEMBLY |
| Classification | Blade-form Endosseous Dental Implant |
| Applicant | ORATRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | NRQ |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-25 |
| Decision Date | 1979-10-09 |