| Primary Device ID | 00883205103253 |
| NIH Device Record Key | d0f82848-8501-44f4-b086-53412ba6fd11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opal Seal |
| Version Model Number | 500060 |
| Catalog Number | 500060 |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205103253 [Primary] |
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| 00883205103284 | Opal Seal Trial Syringe |
| 00883205103277 | Opal Seal Refill |
| 00883205103260 | Opal Seal Kit |
| 00883205103253 | Opal Seal Intro Kit |
| 00883205103239 | Opal Seal Adhesives Trial Kit |
| 00883205015709 | Metal Opal Seal Tips 500pk |
| 00883205015686 | Metal Opal Seal Tips 100 Pack |
| 00883205015679 | Metal Opal Seal Tips 20 Pack |
| 00883205015488 | Opal Seal Tips 20 Pack |
| 00883205015266 | Opal Seal Tips 100 Pack |