| Primary Device ID | D0026562912 |
| NIH Device Record Key | 8d851b62-072b-4cfe-9946-5ff2a8ae74e0 |
| Commercial Distribution Discontinuation | 2023-03-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules |
| Version Model Number | 656291 |
| Catalog Number | 656291 |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| Device Count | 500 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026562910 [Unit of Use] |
| HIBCC | D0026562911 [Primary] |
| HIBCC | D0026562912 [Package] Contains: D0026562911 Package: Case [4 Units] Discontinued: 2023-02-28 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 | 2023-03-27 |
| Device Publish Date | 2016-09-21 |
| D0026562932 | Dispersed Phase Alloy, Regular Set, 3 Spill, 2000 (800mg) Yellow/White caps |
| D0026562922 | Dispersed Phase Alloy, Regular Set, 2 Spill, 2000 (600mg) Blue/White caps |
| D0026562912 | Dispersalloy Dispersed Phase Alloy, Regular Set, 1 Spill, 2000 (400mg) Green/White caps |
| D0026562612 | Dispersed Phase Alloy, Fast Set, 1 Spill, 2000 (400mg) Green/White caps |
| D0026562622 | Dispersed Phase Alloy, Fast Set, 2 Spill, 2000 (600mg) Blue/White caps |
| D00265628932 | Dispersed Phase Alloy, Regular Set, 3 Spill, 500 (800mg) Yellow caps |
| D00265628922 | Dispersed Phase Alloy, Regular Set, 2 Spill, 500 (600mg) Blue/White caps |
| D00265628912 | Dispersed Phase Alloy, Regular Set, 1 Spill, 500 (400mg) Green caps |
| D00265628632 | Dispersed Phase Alloy, Fast Set, 3 Spill, 500 (800mg) Yellow caps |
| D00265628622 | Dispersed Phase Alloy, Fast Set, 2 Spill, 500 (600mg) Blue/White caps |
| D00265628612 | Dispersed Phase Alloy, Fast Set, 1 Spill, 500 (400mg) Green caps |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DISPERSALLOY 72304837 0868727 Live/Registered |
UNITEK CORPORATION 1968-08-09 |