| Primary Device ID | D801SP515011 |
| NIH Device Record Key | 98cd2b7d-5751-40a8-a227-5ae6c10a0bdd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SciPharm Eugenone Temporary Cement |
| Version Model Number | SP 51-501 |
| Catalog Number | 51-501 |
| 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 Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D801SP515011 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-03 |
| D801SP515011 | Eugenol Free Temporary Crown and Bridge Cement in Automix Dispensing System. Zinc Oxide Based. |
| D801SP51501 | Eugenol Free Temporary Crown and Bridge Cement in Automix Dispensing System. Zinc Oxide Based. |