| Primary Device ID | D801SP55401 |
| NIH Device Record Key | ebf5bd61-19d5-4511-821d-870fca744314 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SciPharm InterCem Temporary Cement |
| Version Model Number | SP 55-40 |
| Catalog Number | 55-40 |
| 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 | 909-595-9922 |
| Denise@scipharm.com | |
| Phone | 909-595-9922 |
| 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 | D801SP55401 [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 | 2016-08-09 |
| D801SP55411 | InterCem - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants |
| D801SP55401 | InterCem - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants |