| Device Type ID | 1090 |
| Device Name | Adhesive, Bracket And Tooth Conditioner, Resin |
| Regulation Description | Bracket Adhesive Resin And Tooth Conditioner. |
| 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 | 872.3750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DYH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1090 |
| Device | Adhesive, Bracket And Tooth Conditioner, Resin |
| Product Code | DYH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bracket Adhesive Resin And Tooth Conditioner. |
| CFR Regulation Number | 872.3750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMERICAN ORTHODONTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DANVILLE MATERIALS, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GC ORTHODONTICS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PULPDENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VOCO GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Patient-Device Incompatibility | 2 |
| Total Device Problems | 6 |