| Primary Device ID | D687720661 | 
| NIH Device Record Key | 43d4207f-fddd-4a04-8d61-dc11896ab9ab | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Versa-Temp® | 
| Version Model Number | 72066 | 
| Company DUNS | 056296981 | 
| Company Name | Sultan Healthcare Inc | 
| Device Count | 3 | 
| 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 | false | 
| 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 | 
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | |
| Phone | +1(800)989-8825 | 
| xx@xx.xx | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Total Volume | 50 Milliliter | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Special Storage Condition, Specify | Between 0 and 0 *Protect against heat and sunlight. Keep dry. | 
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D687720660 [Unit of Use] | 
| HIBCC | D687720661 [Primary] | 
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2021-10-29 | 
| Device Publish Date | 2016-09-23 | 
| D687720901 | Versa-Temp® A3 Crown and Bridge Resin 5ml syringe - 5 tips | 
| D687720851 | Versa-Temp® A2 Crown and Bridge Resin 5ml syringe - 5 tips | 
| D687720801 | Versa-Temp® Temporary Crown and Bridge Resin A1 5ml syringe 5 tips | 
| D687720761 | Versa-Temp® 2 Temporary Crown & Bridge Material - A3 3x50ml | 
| D687720751 | Versa-Temp® A3 Crown and Bridge Resin 50ml, Bulk (3 x 50ml) | 
| D687720711 | Versa-Temp® 2 Temporary Crown & Bridge Material - A2 3x50ml | 
| D687720701 | Versa-Temp® A2 Crown and Bridge Resin 50ml Bulk (3 x 50ml) | 
| D687720661 | Versa-Temp® 2 Temporary Crown & Bridge Material - A1 3x50ml | 
| D687720651 | Versa-Temp® A1 Crown and Bridge Resin 50ml Bulk (3 x 50ml) | 
| D687720611 | Versa-Temp® 2 Temporary Crown & Bridge Material - A3 50ml | 
| D687720601 | Versa-Temp® A3 Crown and Bridge Resin 50ml - 15 tips | 
| D687720561 | Versa-Temp® 2 Temporary Crown and Bridge Resin 2 5mL | 
| D687720551 | Versa-Temp® A2 Crown and Bridge Resin 50ml - 15 tips | 
| D687720511 | Versa-Temp® 2 Temporary Crown & Bridge Resin A1 50ml | 
| D687720501 | Versa-Temp® Temporary Crown and Bridge Resin A1 Crown and Bridge Resin 50ml 15 tips | 
| D687720411 | Versa-Temp® 2 Temporary Crown & Bridge Resin-Shade BL, 50ml ca | 
| D687720301 | Versa-Temp® Shade B-1 Crown & Bridge Resin Refill, 25 ml, dispenser gun, 40 tips | 
| D687720251 | Versa-Temp® Shade A-3.5 Crown & Bridge Resin Refill, 25ml, dispenser gun, 40 tips | 
| D687720201 | Versa-Temp® Shade A-2 Crown & Bridge Resin-Refill, 25 ml, dispenser gun, 40 tips | 
| D687720151 | Versa-Temp® Shade A-1 Crown & Bridge Resin Refill, 25 ml, dispenser gun, 40 tips | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VERSA-TEMP  75655052  2468811 Live/Registered | DENTSPLY SIRONA INC. 1999-03-05 | 
|  VERSA-TEMP  73223647  1159029 Dead/Cancelled | McGraw-Edison Company 1979-07-16 | 
|  VERSA-TEMP  73018829  1012844 Dead/Expired | ELECTRONIC DEVELOPMENT LABORATORIES, INC. 1974-04-15 |