| Primary Device ID | D0026030142 |
| NIH Device Record Key | 0295d66e-c678-4792-97dd-6bf51d063e91 |
| Commercial Distribution Discontinuation | 2021-08-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Megalloy®EZ Spherical Amalgam |
| Version Model Number | 603014 |
| Catalog Number | 603014 |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| Device Count | 250 |
| DM Exempt | true |
| 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 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Weight | 400 Milligram |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026030140 [Unit of Use] |
| HIBCC | D0026030141 [Primary] |
| HIBCC | D0026030142 [Package] Contains: D0026030141 Package: Case [4 Units] Discontinued: 2021-07-30 Not in Commercial Distribution |
| EJJ | Alloy, amalgam |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-12-20 |
| Device Publish Date | 2016-09-21 |
| D0026030042 | Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 1 Spill (Red) |
| D0026030162 | Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 3 Spill Case (Lime Green) |
| D0026030152 | Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 2 Spill Case (Purple) |
| D0026030062 | Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 3 Spill (Lime Green) |
| D0026030052 | Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 2 Spill (Purple) |
| D0026030142 | Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 1 Spill Case (Red) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEGALLOY 74677604 1963488 Live/Registered |
DENTSPLY SIRONA INC. 1995-05-19 |
![]() MEGALLOY 73235982 1153632 Live/Registered |
Flexible Steel Lacing Company 1979-10-22 |
![]() MEGALLOY 73123272 1079685 Dead/Expired |
FLEXIBLE STEEL LACING COMPANY 1977-04-18 |