| Device Type ID | 1252 |
| Device Name | Cement, Dental |
| Regulation Description | Dental Cement. |
| 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 | 872.3275 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EMA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1252 |
| Device | Cement, Dental |
| Product Code | EMA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Dental Cement. |
| CFR Regulation Number | 872.3275 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
3M COMPANY, 3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BISCO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLTENE HOLDING AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENALI CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXACTA DENTAL DIRECT, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GC AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ITENA CLINICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KURARAY NORITAKE DENTAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KURARAY NORITAKE DENTAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SHANDONG HUGE DENTAL MATERIAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPIDENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STEINER LABORATORIES, A DIVISION OF STEINER HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TOKUYAMA DENTAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VOCO GMBH | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 64 |
Patient-Device Incompatibility | 24 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Loss Of Or Failure To Bond | 2 |
Compatibility Problem | 2 |
Material Integrity Problem | 2 |
Failure To Adhere Or Bond | 1 |
Hole In Material | 1 |
Material Perforation | 1 |
Insufficient Information | 1 |
Missing Value Reason | 1 |
| Total Device Problems | 113 |