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 |