| Primary Device ID | D7981BGS0 |
| NIH Device Record Key | 40f2a1e1-71b1-40af-8cee-a733b6d323f2 |
| Commercial Distribution Discontinuation | 2016-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Blue Gel Etchant |
| Version Model Number | 1BGS |
| Catalog Number | 1BGS |
| 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 *Store at room temperature (15-30 Degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (15-30 Degrees C) |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7981BGS0 [Primary] |
| 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 |
| D798BEGS1 | Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility |
| D7981BGS0 | Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility |
| D7981BEGS0 | Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility |