| Primary Device ID | D801ID55301I1 |
| NIH Device Record Key | ed1c9bcc-a2a0-41c2-9798-cfff8ba42902 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | International Dental Supply Support Self Cured Core Build-Up Restorative |
| Version Model Number | ID 55-301 I |
| Catalog Number | 55-301 |
| Company DUNS | 096010525 |
| Company Name | SCIENTIFIC PHARMACEUTICALS, INC. |
| Device Count | 1 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 800-634-3047 |
| Denise@scipharm.com | |
| Phone | 800-634-3047 |
| Denise@scipharm.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D801ID55301I1 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-11 |
| D801ID55304I1 | CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Paste Syringe. B |
| D801ID55303I1 | CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Liquid Bottle. I |
| D801ID55302I1 | CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Part A, Natural Syringe. B |
| D801ID55301I1 | CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Contrast Syringe. Boxed. |