Primary Device ID | 00817441023433 |
NIH Device Record Key | baa8c435-6df0-4969-afa9-356908e98c5b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prime Dent Tray Adhesive Blue |
Version Model Number | 017-020 |
Company DUNS | 027480775 |
Company Name | PRIME DENTAL |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817441023433 [Primary] |
ELW | Material, Impression |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-01-04 |
00817441022658 - Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive | 2023-11-29 A 5th generation, single component, multi-use adhesive and glue. |
00817441023136 - Prime Dent Etchant Liquid | 2023-11-29 Etchant gel and conditioner. |
00817441023549 - Scott's Select RC Cream 2-9gm Syringe | 2020-05-06 Scott's Select RC Cream 2-9gm Syringe |
00817441020012 - Prime Dent Visible Light Cure Nano Hybrid Composite Shade | 2019-11-14 Restorative Composite |
00817441020029 - Prime Dent Visible Light Cure Nano Hybrid Composite | 2019-11-14 Restorative Composite |
00817441022269 - Prime-Crown | 2019-11-14 temporary Crown material |
00817441020005 - Prime-Dent Visible Light Cure Nano-Hybrid Composite | 2018-07-06 Visible Light Cure Nano-Hybrid Composite |
00817441023556 - Prime-Core Chemical Cure Core Build Up | 2018-07-06 Prime Core Chemical Cure Core Build Up Kit 15g/15g WHITE |