The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Miter Endosteal Blade Implant.
| Device ID | K791204 |
| 510k Number | K791204 |
| Device Name: | MITER ENDOSTEAL BLADE IMPLANT |
| Classification | Blade-form Endosseous Dental Implant |
| Applicant | DEPUY, 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 | 1979-06-28 |
| Decision Date | 1979-09-28 |