| Primary Device ID | D00265628302 |
| NIH Device Record Key | 136371a6-01d1-4428-9d83-062aa438444d |
| Commercial Distribution Discontinuation | 2024-06-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Dispersalloy® Dispersed Phase Alloy |
| Version Model Number | 656-2830 |
| Catalog Number | 656-2830 |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| Device Count | 20 |
| 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 | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 Milligram |
| Device Size Text, specify | 0 |
| Weight | 389 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. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D00265628300 [Unit of Use] |
| HIBCC | D00265628301 [Primary] |
| HIBCC | D00265628302 [Package] Contains: D00265628301 Package: [6 Units] Discontinued: 2024-06-05 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 | 2024-06-06 |
| Device Publish Date | 2016-09-21 |
| D0026562632 | Dispersed Phase Alloy, Fast Set, 3 Spill, 2000 (800mg) Yellow/White caps |
| D00265628292 | Dispersed Phase Alloy, Regular Set Tablets, 120 tubes of 40 (389mg) tablets |
| D00265628212 | Dispersed Phase Alloy, Regular Set Powder, 12 (150g) bottles |
| D00265628222 | Dispersed Phase Alloy, Fast Set Powder, 12 (150g) bottles |
| D00265628302 | Dispersed Phase Alloy, Fast Set Tablets, 120 tubes of 40 (389mg) tablets |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DISPERSALLOY 72304837 0868727 Live/Registered |
UNITEK CORPORATION 1968-08-09 |