| Primary Device ID | D798EGSS1 |
| NIH Device Record Key | 3f5102d3-8d6e-4df4-be62-5e0114b456b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gel Etchant |
| Version Model Number | EGSS |
| Catalog Number | EGSS |
| Company DUNS | 113170088 |
| Company Name | RELIANCE ORTHODONTIC PRODUCTS 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 6307734009 |
| paulgropi@aol.com | |
| Phone | 6307734009 |
| paulgropi@aol.com |
| Special Storage Condition, Specify | Between 0 and 0 *Storage at room temperature (15-30 Degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage at room temperature (15-30 Degrees C) |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D798EGSS0 [Primary] |
| HIBCC | D798EGSS1 [Package] Contains: D798EGSS0 Package: Bag [5 Units] In Commercial Distribution |
| KLE | Agent, Tooth Bonding, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-29 |
| Device Publish Date | 2016-09-03 |
| D798EGSS1 | Gel Etchant is intended for use in the etching of enamel surface prior to bonding. This is a 6 |
| D7981EGSS0 | Gel Etchant is intended for use in the etching of enamel surface prior to bonding. This is a 6 |
| D7981EGSSAM0 | 1EGSSSAM |
| D7981BEGSSAM0 | 1BEGSSAM |