Definition: It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.
Device Type ID | 1370 |
Device Name | Implant, Endosseous, Orthodontic |
Physical State | Generally Fabricated From Titanium Or Titanium Alloy In A Screw Form Or Screw And Plate Combination. |
Technical Method | It Is Surgically Placed In The Bone Of The Upper Or Lower Jaw Arches To Provide Support For Orthodontic Devices. |
Target Area | Maxilla And Mandibular Jaw Bone. |
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 | OAT |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1370 |
Device | Implant, Endosseous, Orthodontic |
Product Code | OAT |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endosseous Dental Implant. |
CFR Regulation Number | 872.3640 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
BOMEI CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTAL MORELLI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JEIL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSTEM IMPLANT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Device Problems | |
---|---|
Loose Or Intermittent Connection | 23 |
Device Operates Differently Than Expected | 4 |
Bent | 2 |
Break | 2 |
Device Dislodged Or Dislocated | 1 |
Total Device Problems | 32 |