The following data is part of a premarket notification filed by Factor, Ii, Inc. with the FDA for Magna Abutment.
| Device ID | K984297 |
| 510k Number | K984297 |
| Device Name: | MAGNA ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | FACTOR, II, INC. 1972 FOREST AVE. Lakeside, AZ 85929 |
| Contact | John D Mcfall |
| Correspondent | John D Mcfall FACTOR, II, INC. 1972 FOREST AVE. Lakeside, AZ 85929 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-01 |
| Decision Date | 2000-01-28 |