| Primary Device ID | D801SP62011B1 |
| NIH Device Record Key | 51dcf90f-1cfd-4b13-b6d9-e7a3047040b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SciPharm Band Secure Orthodontic Band Cement |
| Version Model Number | SP 62-011 B |
| Catalog Number | 62-011 |
| 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 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D801SP62011B1 [Primary] |
| DYH | Adhesive, Bracket And Tooth Conditioner, 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 | 2018-07-06 |
| Device Publish Date | 2016-08-10 |
| D801SP62011N1 | Band Secure - Orthodontic Band Cement with Fluoride. Non-Boxed. |
| D801SP62011B1 | Band Secure - Orthodontic Band Cement with Fluoride. Boxed. |
| D801SP62011 | Band Secure - Orthodontic Band Cement with Fluoride. |