| Primary Device ID | 00883205103673 |
| NIH Device Record Key | 020da806-5f7b-457e-a180-aa62f715beb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PQ4 |
| Version Model Number | 641 |
| Catalog Number | 641 |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205103673 [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 |
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| 00883205032270 - Chromaclone | 2025-03-19 Chromaclone PVS Heavy Fast Set Econo Refill |
| 00883205032287 - Chromaclone | 2025-03-19 Chromaclone PVS Medium Regular Set Refill |