| Primary Device ID | 00883205104205 |
| NIH Device Record Key | f3a4abe2-e173-40f1-b5fc-8744359dc9e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Composite Wetting Resin |
| Version Model Number | 3059 |
| Catalog Number | 3059 |
| 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 | 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 |
| 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 | 00883205104205 [Primary] |
| KLE | AGENT, TOOTH BONDING, 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 |
| 00883205031778 - Ultrapak | 2024-04-03 Sample Cord Ultradent |
| 00883205034168 - VALO | 2024-03-04 VALO X ProxiCure Ball Lens 2pk |
| 00883205034175 - VALO | 2024-03-04 VALO X PointCure Lens 2pk |
| 00883205034182 - VALO | 2024-03-04 VALO X TransLume Lens 2pk |
| 00883205034199 - VALO | 2024-03-04 VALO X Interproximal Lens 2pk |
| 00883205034205 - VALO | 2024-03-04 VALO X Diffuser Lens 1pk |
| 00883205027948 - PermaShade Try-In Paste | 2024-01-19 PermaShade Try-In Paste Kit |
| 00883205027955 - PermaShade Try-In Paste | 2024-01-19 PermaShade Try-In Paste Translucent Refill |