| Device Type ID | 1122 |
| Device Name | Crown And Bridge, Temporary, Resin |
| Regulation Description | Temporary Crown And Bridge Resin. |
| 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 | 872.3770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EBG |
| 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 | 1122 |
| Device | Crown And Bridge, Temporary, Resin |
| Product Code | EBG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Temporary Crown And Bridge Resin. |
| CFR Regulation Number | 872.3770 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY, 3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BLUE DENT DENTAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTAL DIREKT GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTALPLUS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTIS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DREVE DENTAMID GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GC AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HARVEST DENTAL PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IVOCLAR VIVADENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RIZHAO HUGE DENTAL INDUSTRY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCHUTZ DENTAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TALLADIUM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE ARGEN CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UNION DENTAL S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIRKONZAHN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 7 |
Insufficient Information | 5 |
Malposition Of Device | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Structural Problem | 2 |
Device Operates Differently Than Expected | 2 |
Fracture | 2 |
Positioning Problem | 2 |
Difficult To Position | 2 |
Defective Device | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Positioning Failure | 2 |
Device-Device Incompatibility | 1 |
Break | 1 |
Defective Component | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 39 |