ULTRADENT PRODUCTS, INC.
13 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (13)
Registered facilities (1)
- Ultradent Products Inc. FEI 1718912 · UT
Recalls & enforcement
20261 record
- Class IIOngoing2026-01-28Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
20241 record
- Class IIOngoing2024-08-02Due to a manufacturing issue, red particulates present in the expressed composite.
20221 record
- Class IICompleted2022-06-01SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
20201 record
- Class IITerminated2020-08-31Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
20181 record
- Class IITerminated2018-07-12Dental varnish has the possibility of having an unpleasant and off flavor.
20171 record
- Class IITerminated2017-08-04The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
20162 records
- Class IITerminated2016-12-14Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
- Class IITerminated2016-11-17There 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.
20151 record
- Class IITerminated2015-12-22Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.
20133 records
- Class IIITerminated2013-11-19Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
- Class IIITerminated2013-02-08Orthodontic brackets distributed was incorrectly labeled.
- Class IIITerminated2013-02-04Incorrect packaging of regular set and fast set cartridges.
20121 record
- Class IITerminated2012-05-24Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedu…
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “ULTRADENT PRODUCTS, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1718962-ultradent-products-inc/
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