Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K200752
DB-Orthopedics · Dimensional Bioceramics, LLC · decided 2020-04-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| OsteoRepair-Inject | DB-O-I5CC | DIMENSIONAL BIOCERAMICS LLC | MQV | 00850018568050 |
| OsteoRepair-Inject | DB-O-I3CC | DIMENSIONAL BIOCERAMICS LLC | MQV | 00850018568043 |
| OsteoRepair-Inject | DB-O-I20CC | DIMENSIONAL BIOCERAMICS LLC | MQV | 00850018568074 |
| OsteoRepair-Inject | DB-O-I10CC | DIMENSIONAL BIOCERAMICS LLC | MQV | 00850018568067 |
| OsteoRepair-Paste | DB-O-P10CC | DIMENSIONAL BIOCERAMICS LLC | MQV | 00850018568029 |
| OsteoRepair-Paste | DB-O-P20CC | DIMENSIONAL BIOCERAMICS LLC | MQV | 00850018568036 |
| OsteoRepair-Paste | DB-O-P5CC | DIMENSIONAL BIOCERAMICS LLC | MQV | 00850018568012 |
| OsteoRepair-Paste | DB-O-P3CC | DIMENSIONAL BIOCERAMICS LLC | MQV | 00850018568005 |