Versa-Temp®
GUDID D687720761
Versa-Temp® 2 Temporary Crown & Bridge Material - A3 3x50ml
Sultan Healthcare Inc
Temporary dental crown/bridge| Primary Device ID | D687720761 |
| NIH Device Record Key | 6478797d-50ad-4218-84be-f90b3f50bde9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versa-Temp® |
| Version Model Number | 72076 |
| 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 |
Customer Support Contacts
| 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 |
Device Dimensions
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D687720760 [Unit of Use] |
| HIBCC | D687720761 [Primary] |
FDA Product Code
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN |
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 | 2021-10-29 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Versa-Temp®]
| 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 |
Trademark Results [Versa-Temp]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.