| Primary Device ID | 00348783001266 |
| NIH Device Record Key | aadb838f-0bef-4659-a81a-67bfde6d5a71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gynex Acetic Acid |
| Version Model Number | AA312 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00348783001266 [Primary] |
| IGF | Solution, Formalin-Alcohol-Acetic Acid |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2023-06-01 |
| 00348783013283 - Traxodent | 2025-02-07 Traxodent Unit Dose Value Pack |
| 00348783012699 - BufferPro | 2024-12-26 BufferPro Box of 25 Units |
| 00348783003529 - Cure-Thru Integra Post | 2024-09-27 Cure-Thru Integra Post (10) - Size 4 |
| 00348783003536 - Cure-Thru Integra Post | 2024-09-27 Cure-Thru Integra Post (10)- Size 4.5 |
| 00348783003543 - Cure-Thru Integra Post | 2024-09-27 Cure-Thru Integra Post (10)- Size 5 |
| 00348783003550 - Cure-Thru Integra Post | 2024-09-27 Cure-Thru Integra Post (10)- Size 6 |
| 10348783005599 - Enamel Pro Varnish | 2024-09-27 EP Varnish Straw 'N Cream .40 ml (35) |
| 10348783005605 - Enamel Pro Varnish | 2024-09-27 EP Varnish Bubblegum .40 ml (35) |