Primary Device ID | 00883205033437 |
NIH Device Record Key | 9c382f68-b255-41ab-8d69-59e9f05f08b1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UltraSeal XT |
Version Model Number | 1286 |
Catalog Number | 1286 |
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 | 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)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
customerservice@ultradent.com | |
Phone | +1(801)553-4200 |
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 |
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 | 00883205033437 [Primary] |
GS1 | 00883205104120 [Previous] |
EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-11-12 |
Device Publish Date | 2021-11-04 |
00883205104199 | U-Seal XT Hydro Kit OP White |
00883205104182 | U-Seal XT Hydro Kit Natural |
00883205104175 | U-Seal XT Hydro Refill OP White |
00883205104168 | U-Seal XT Hydro Refill Natural |
00883205104151 | U-Seal XT Hydro Econo Refill OP White |
00883205104120 | UltraSeal XT plus Shade A1 Kit |
00883205104106 | UltraSeal XT plus Shade A1 Refill |
00883205103819 | UltraSeal XT Plus Opaque White Kit |
00883205103802 | UltraSeal XT Plus Opaque White Refill |
00883205103796 | UltraSeal XT Plus Opaque White Econo Refill |
00883205103765 | UltraSeal XT Plus Shade A2 Kit |
00883205103758 | UltraSeal XT Plus Shade A2 Refill |
00883205103666 | UltraSeal XT Plus Clear Refill |
00883205103550 | UltraSeal XT Plus Clear Kit |
00883205102645 | UltraSeal XT Plus Unit Dose 50pk |
00883205101310 | UltraSeal XT Hydro Unit Dose 50pk OP White |
00883205033468 | UltraSeal XT Plus Shade A2 Kit |
00883205033437 | UltraSeal XT plus Shade A1 Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ULTRASEAL XT 74405208 1826080 Live/Registered |
Ultradent Products, Inc. 1993-06-18 |