The following data is part of a premarket notification filed by American Implant Technology, Inc. with the FDA for Ait Implant System.
| Device ID | K915865 |
| 510k Number | K915865 |
| Device Name: | AIT IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | AMERICAN IMPLANT TECHNOLOGY, INC. 2B MOULTON ST. Georgetown, MA 01833 |
| Contact | Leland J Peters |
| Correspondent | Leland J Peters AMERICAN IMPLANT TECHNOLOGY, INC. 2B MOULTON ST. Georgetown, MA 01833 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-31 |
| Decision Date | 1992-11-04 |