Definition: Device Made Of A Material Such As Titanium Or Titanium Alloy, That Is Intended To Be Surgically Placed In The Bone Of The Upper Or Lower Jaw Arches To Provide Support For Prosthetic Devices, Such As Artificial Teeth, In Order To Restore A Patient's C
Device Type ID | 1354 |
Device Name | Blade-form Endosseous Dental Implant |
Regulation Description | Endosseous Dental Implant. |
Regulation Medical Specialty | Dental |
Review Panel | Dental |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
Submission Type | 510(k) |
CFR Regulation Number | 872.3640 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NRQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1354 |
Device | Blade-form Endosseous Dental Implant |
Product Code | NRQ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endosseous Dental Implant. |
CFR Regulation Number | 872.3640 [🔎] |