| Primary Device ID | D033099650131 |
| NIH Device Record Key | d1697dd4-4744-4d77-888f-8ce2bfc100d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZenithDental Royale Dispersed Phase High Copper |
| Version Model Number | 65013 |
| Catalog Number | 099-65013 |
| Company DUNS | 106792427 |
| Company Name | DMG AMERICA, LLC |
| Device Count | 500 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Celsius and 25 Degrees Celsius |
| D033099651051 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 100 jar |
| D033099651041 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 100 jar |
| D033099651031 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 100 jar |
| D033099650151 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 500 jar |
| D033099650141 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 500 jar |
| D033099650131 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 500 jar |
| D033099650091 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 50 jar |
| D033099650081 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 50 jar |
| D033099650071 | ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 50 jar |