| Device Type ID | 1121 |
| Device Name | Material, Tooth Shade, Resin |
| Regulation Description | Tooth Shade Resin Material. |
| 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 | 872.3690 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EBF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1121 |
| Device | Material, Tooth Shade, Resin |
| Product Code | EBF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tooth Shade Resin Material. |
| CFR Regulation Number | 872.3690 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
3M COMPANY, 3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BICON, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BISCO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BREDENT GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLTENE HOLDING AG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DENALI CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENMAT HOLDINGS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GC AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
IVOCLAR VIVADENT AG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
JUNO DENTISTRY LP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KERR CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KETTENBACH GMBH & CO KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KURARAY NORITAKE DENTAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIAONING UPCERA CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERZ DENTAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
META BIOMED CO, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOVA BIOMATERIALS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOVA BIOMATERIALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVOCOL, INC., SEPTODONT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARKELL INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PRISMATIK | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PULPDENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCHUTZ DENTAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHOFU DENTAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
SYBRON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON DENTAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOKUYAMA DENTAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ULTRADENT PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VERICOM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITA ZAHNFABRIK H. RAUTER GMBH & CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VOCO GMBH | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
ZIRKONZAHN SRL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 235 |
Patient-Device Incompatibility | 20 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Missing Value Reason | 6 |
Insufficient Information | 2 |
Fracture | 2 |
Device Operates Differently Than Expected | 1 |
Failure To Adhere Or Bond | 1 |
Material Integrity Problem | 1 |
Loss Of Or Failure To Bond | 1 |
Unintended Ejection | 1 |
Nonstandard Device | 1 |
Torn Material | 1 |
| Total Device Problems | 281 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Jul-08-2015 |
| 2 | Ivoclar Vivadent, Inc. | III | Feb-21-2018 |