| Primary Device ID | 00883205103000 |
| NIH Device Record Key | f6e949f2-dae1-4d92-bb4d-25c3e5078381 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PermaShade LC |
| Version Model Number | S3517 |
| Catalog Number | S3517 |
| 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 | 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 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205103000 [Primary] |
| EMA | CEMENT, DENTAL |
| 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 |
| 00883205107619 | PermaShade LC Veneer Cement Kit |
| 00883205106766 | PermaShade LC Light Cure Veneer Cement Refill - B1 |
| 00883205106759 | PermaShade LC Light Cure Veneer Cement Refill - A2 |
| 00883205106742 | PermaShade LC Light Cure Veneer Cement Refill - Opaque White |
| 00883205106735 | PermaShade LC Veneer Cement Refill -Translucent |
| 00883205103000 | Sample PermaShade LC Veneer Cement Translucent |
| 00883205019240 | PermaShade LC Veneer Cement Kit |