Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules 656261
GUDID D0026562612
Dispersed Phase Alloy, Fast Set, 1 Spill, 2000 (400mg) Green/White caps
DENTSPLY INTERNATIONAL INC.
Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy| Primary Device ID | D0026562612 |
| NIH Device Record Key | 460e636e-3c37-4284-8eb5-7a6107698b8d |
| Commercial Distribution Discontinuation | 2021-08-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules |
| Version Model Number | 656261 |
| Catalog Number | 656261 |
| 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 |
Customer Support Contacts
Device Dimensions
| 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 |
| Weight | 400 Milligram |
Operating and Storage Conditions
| 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026562610 [Unit of Use] |
| HIBCC | D0026562611 [Primary] |
| HIBCC | D0026562612 [Package] Contains: D0026562611 Package: Case [4 Units] Discontinued: 2021-07-31 Not in Commercial Distribution |
FDA Product Code
| EJJ | Alloy, amalgam |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-12-19 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules]
| 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 |
Trademark Results [Dispersalloy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DISPERSALLOY 72304837 0868727 Live/Registered |
UNITEK CORPORATION 1968-08-09 |
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