The following data is part of a premarket notification filed by Hati Dental Ag. with the FDA for Ha-ti (hand Titanium Screw) Implant.
| Device ID | K003045 |
| 510k Number | K003045 |
| Device Name: | HA-TI (HAND TITANIUM SCREW) IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HATI DENTAL AG. 252 W. RIDLEY AVE. Ridley Park, PA 19078 |
| Contact | Heinz E Wick |
| Correspondent | Heinz E Wick HATI DENTAL AG. 252 W. RIDLEY AVE. Ridley Park, PA 19078 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-29 |
| Decision Date | 2001-07-12 |