FDA-Device2016-12-14Class II
UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
Ultradent Products, Inc.
Hazard
There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.
Sold states
Worldwide Distribution - US Nationwide
Affected count
31
Manufactured in
505 W 10200 S, N/A, South Jordan, UT, United States
Products
UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0704-2017Don't want to check this manually?
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