Z-0704-2017Class II

UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus

Name: Z-0704-2017 UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus
Creator: Ultradent Products, Inc.
Published: 2016-11-17
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2016-11-17 / Terminated / root cause: labeling and UDI

FDA source

Ultradent Products, Inc. began a recall of 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... on 2016-11-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0704-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-17
Posted: 2016-12-03
Terminated: 2017-06-05
Recalling firm: Ultradent Products Inc.
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.
Product code: EBC Sealant, Pit And Fissure, And Conditioner
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees notified via phone on 17Nov2016 and by letter on 22Nov2016 to identify and return products. Consignees with any questions regarding this field action can be sent to 801-553-4858 or 801-553-4220.
Quantity in commerce: 31
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Lot BD79T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0704-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0704-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-03

Product code EBC

K993846Class IIUltraseal Xt PlusUltradent Products, Inc. / cleared 2000-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)