| Primary Device ID | 00883205032638 |
| NIH Device Record Key | 34affb91-59aa-423c-854b-d8823b9139df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OpalCups |
| Version Model Number | 5172 |
| Catalog Number | 5172 |
| 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 | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205032638 [Primary] |
| EHK | CUP, PROPHYLAXIS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-19 |
| Device Publish Date | 2025-03-11 |
| 00883205031501 - Jiffy | 2025-09-29 Jiffy Composite Adjusting & Polishing Kit |
| 00883205031983 - ExperTemp | 2025-09-01 ExperTemp A2 kit |
| 00883205031990 - ExperTemp | 2025-09-01 ExperTemp A1 kit |
| 00883205032003 - ExperTemp | 2025-09-01 ExperTemp A3.5 Kit |
| 00883205032010 - ExperTemp | 2025-09-01 ExperTemp B1 kit |
| 00883205032027 - ExperTemp | 2025-09-01 ExperTemp Bleach White kit |
| 00883205032041 - ExperTemp | 2025-09-01 ExperTemp Mixing Tip Refill 45pk |
| 00883205032058 - ExperTemp | 2025-09-01 ExperTemp A3 kit |