Primary Device ID | 00348783001259 |
NIH Device Record Key | 72f6c0d2-3623-4dfe-8bbf-16b610be1d37 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Premier Acetic Acid |
Version Model Number | 9045052 |
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 | 00348783001259 [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 | 2023-05-17 |
Device Publish Date | 2023-05-09 |
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 |