The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Monoject Endosseous Dental Implant.
| Device ID | K781060 |
| 510k Number | K781060 |
| Device Name: | MONOJECT ENDOSSEOUS DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-26 |
| Decision Date | 1978-08-14 |