The following data is part of a premarket notification filed by Titan Implants with the FDA for Titanium Abutment Heads For Imz Implants.
| Device ID | K003818 |
| 510k Number | K003818 |
| Device Name: | TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | TITAN IMPLANTS 203 MAIN STREET, PMB 166 Flemington, NJ 08822 |
| Contact | Lynette L Howard |
| Correspondent | Lynette L Howard TITAN IMPLANTS 203 MAIN STREET, PMB 166 Flemington, NJ 08822 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-11 |
| Decision Date | 2001-07-05 |