| Primary Device ID | D798DB0 |
| NIH Device Record Key | 5047c581-fdf4-485b-b2ac-8862f54cc5fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Renew System |
| Version Model Number | DB |
| Catalog Number | DB |
| Company DUNS | 113170088 |
| Company Name | RELIANCE ORTHODONTIC PRODUCTS INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 6307734009 |
| paulgropi@aol.com | |
| Phone | 6307734009 |
| paulgropi@aol.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in ambient conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in ambient conditions. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D798DB0 [Primary] |
| EJL | Bur, 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 | 2020-03-23 |
| Device Publish Date | 2016-07-25 |
| D7981TKOC150 - TKO Clear | 2024-08-09 |
| D798TKOC150 - TKO Clear | 2024-08-09 |
| D79821BTIPS101 - Brush Tips | 2023-12-21 |
| D798RBTA0 - Tweezers | 2023-12-21 |
| D798RBTP0 - Tweezers | 2023-12-21 |
| D798RBX0 - ReliaBox | 2023-12-21 ReliaBox |
| D798RBXK0 - ReliaBox | 2023-12-21 ReliaBox Kit |
| D7981BEGSSAM0 - Gel Etchant | 2023-09-27 |