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 |