| Primary Device ID | 00883205019455 |
| NIH Device Record Key | 0d390892-9151-4727-9072-aff12f0ae137 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UltraPro Tx |
| Version Model Number | S8301 |
| Catalog Number | S8301 |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, INC. |
| 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 | true |
| 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 | +1(801)572-4200 |
| customerservice@ultradent.com |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205019455 [Primary] |
| EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-30 |
| Device Publish Date | 2018-06-27 |
| 00883205026293 | Ultrapro Tx Disposable Prophy Pointed Brush Tip 100 pack |
| 00883205026279 | Ultrapro Tx skini Contra Disposable Prophy Angles Firm 500 pack |
| 00883205026262 | Ultrapro Tx skini Contra Disposable Prophy Angles Firm 144 pack |
| 00883205026255 | Ultrapro Tx skini Contra Disposable Prophy Angles Soft 500 pack |
| 00883205026248 | Ultrapro Tx skini Contra Disposable Prophy Angles Soft 144 pack |
| 00883205026231 | Ultrapro Tx skini Disposable Prophy Angles Firm 500 pack |
| 00883205026224 | Ultrapro Tx skini Disposable Prophy Angles Firm 144 pack |
| 00883205026217 | Ultrapro Tx skini Disposable Prophy Angles Soft 500 pack |
| 00883205026200 | Ultrapro Tx skini Disposable Prophy Angles Soft 144 pack |
| 00883205026187 | Ultrapro Tx Extra Contra Disposable Prophy Angles Firm 500 pack |
| 00883205026170 | Ultrapro Tx extra Contra Disposable Prophy Angles Firm 144 pack |
| 00883205026163 | Ultrapro Tx extra Contra Disposable Prophy Angles Soft 500 pack |
| 00883205026156 | Ultrapro Tx extra Contra Disposable Prophy Angles Soft 144 pack |
| 00883205026149 | Ultrapro Tx extra Disposable Prophy Angles Firm 500 pack |
| 00883205026132 | Ultrapro Tx extra Disposable Prophy Angles Firm 144 pack |
| 00883205026125 | Ultrapro Tx extra Disposable Prophy Angles Soft 500 pack |
| 00883205026118 | Ultrapro Tx extra Disposable Prophy Angles Soft 144 pack |
| 00883205020062 | Ultrapro Tx Prophy Handpiece Motor |
| 00883205020055 | Ultrapro Tx Nose Cone Blue 1 pack |
| 00883205020048 | Ultrapro Tx Nose Cone Bordeaux 1 pack |
| 00883205019455 | Sample UltraPro TX Prophy Paste |
| 00883205004895 | Ultrapro Tx Prophy Handpiece Motor with 3 Nose Cones |
| 00883205004864 | Ultrapro Tx Nose Cone Green 1 pack |
| 00883205029034 | Sample ultrapro Tx Sweep Disposable Prophy Angles 1 firm 1 Soft |
| 00883205029027 | ultrapro Tx Sweep Disposable Prophy Angles Firm 500 pack |
| 00883205029010 | ultrapro Tx Sweep Disposable Prophy Angles Firm 144 pack |
| 00883205029003 | ultrapro Tx Sweep Disposable Prophy Angles Soft 500 pack |
| 00883205028990 | ultrapro Tx Sweep Disposable Prophy Angles Soft 144 pack |
| 00883205033512 | UltraPro Tx Prophy Paste Cool Mint Medium 200 pack |
| 00883205033505 | UltraPro Tx Prophy Paste Cool Mint Fine 200 pack |
| 00883205032621 | UltraPro TX Prophy Paste Medium Variety 200 pack |
| 00883205032614 | UltraPro TX Prophy Paste Fine Variety 200 pack |
| 00883205032607 | UltraPro TX Prophy Paste Pure Medium 200 |
| 00883205032591 | UltraPro TX Prophy Paste Orange Dreamsicle Coarse 200 pack |
| 00883205032584 | UltraPro TX Prophy Paste Orange Dreamsicle Medium 200 pack |
| 00883205032577 | UltraPro TX Prophy Paste Orange Dreamsicle Fine 200 pack |
| 00883205032560 | UltraPro TX Prophy Paste Bubblegum Fine 200 pack |
| 00883205032553 | UltraPro TX Prophy Paste Walterberry Fine 200 pack |
| 00883205032546 | UltraPro Tx Prophy Paste Bubblegum Coarse 200 pack |
| 00883205032539 | UltraPro Tx Prophy Paste Bubblegum Medium 200 pack |
| 00883205032522 | UltraPro Tx Prophy Paste Walterberry Coarse 200 pack |
| 00883205032515 | UltraPro Tx Prophy Paste Walterberry Medium 200 pack |
| 00883205032508 | UltraPro Tx Prophy Paste Cool Mint Coarse 200 pack |