| 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 |
| 00348783012989 - Enamel Pro® Prophy Paste | 2025-07-24 Enamel Pro® Prophy Paste Grape-Medium |
| 00348783005134 - RC-Prep | 2025-07-17 RC PREP PLASTIC 9G SYR TIP REFILL (50) |
| 00348783005141 - RC-Prep | 2025-07-17 RC-PREP 3CC SYRINGE TIP REFILL (50) |
| 00348783005158 - Enamel Pro® Prophy Paste | 2025-07-17 Enamel Pro® Prophy Paste Mint-Fine (Box of 200) |
| 00348783005165 - Enamel Pro® Prophy Paste | 2025-07-17 Enamel Pro® Prophy Paste Mint-Medium |
| 00348783005172 - Enamel Pro® Prophy Paste | 2025-07-17 Enamel Pro® Prophy Paste Mint-Coarse |
| 00348783005189 - Enamel Pro® Prophy Paste | 2025-07-17 Enamel Pro® Prophy Paste Mint-Extra Coarse |
| 00348783005196 - Enamel Pro® Prophy Paste | 2025-07-17 Enamel Pro® Prophy Paste Mint-Coarse-Fluoride free |