Recall Z-0704-2017— Ultradent Products, Inc.

Name: FDA recall Z-0704-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-17

Class II · Terminated

Class II FDA medical device recall by Ultradent Products, Inc., initiated 2016-11-17, terminated 2017-06-05. It names one FDA 510(k) clearance: K993846. Product: 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.. Reason: 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..

Recalling firm: Ultradent Products, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-17
Terminated: 2017-06-05
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K993846 — ULTRASEAL XT PLUSUltradent Products, Inc.·cleared 2000-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.