| Primary Device ID | 00883205015235 |
| NIH Device Record Key | f42f5b08-a008-4485-b237-79a66d18a6c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opal Red |
| Version Model Number | 500018- |
| Catalog Number | 500018- |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205015235 [Primary] |
| KXR | APPLICATOR, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-01 |
| Device Publish Date | 2018-08-31 |
| 00883205030177 - White Mac Tip | 2024-12-25 White Mac Tips 10pk |
| 00883205030900 - VALO | 2024-12-25 VALO GRAND SAPPHIRE (Cordless) |
| 00883205030917 - VALO | 2024-12-25 VALO GRAND RED ROCK (CORDLESS) |
| 00883205030924 - VALO | 2024-12-25 VALO GRAND MIDNIGHT (CORDLESS) |
| 00883205031587 - Thermo Clone VPS | 2024-12-25 Thermo Clone VPS Fast Set Superlight Body 2x50 ml Refill Kit |
| 00883205031709 - Thermo Clone | 2024-12-25 Thermo Clone VPS Fast Set Light Body 10x50 ml Bulk Pack |
| 00883205031716 - Thermo Clone | 2024-12-25 Thermo Clone VPS Fast Set Heavy 10x50 ml Bulk Pack |
| 00883205031860 - Gishy Goo | 2024-12-25 Gishy Goo! One-Patient Kit Tooth Color |