Primary Device ID | 00883205104328 |
NIH Device Record Key | 8fddbe21-2606-4fcd-a229-131a9a334663 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Opalustre |
Version Model Number | 5554 |
Catalog Number | 5554 |
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 | true |
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 | |
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 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00883205104328 [Primary] |
EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY |
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 |
00883205103574 | Opalustre Kit |
00883205103567 | Opalustre Refill |
00883205104328 | Opalustre 2 Pack |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OPALUSTRE 75767451 2460976 Live/Registered |
Ultradent Products, Inc. 1999-08-04 |
OPALUSTRE 75443181 not registered Dead/Abandoned |
ULTRADENT PRODUCTS, INC. 1998-03-02 |