Ultradent Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
23
510(k) Clearances
102
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-3068-2024Class IIBrand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/CataloAugust 2, 2024
Z-3067-2024Class IIBrand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817-August 2, 2024
Z-3066-2024Class IIBrand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- SoftAugust 2, 2024
Z-1368-2022Class IIPeak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part:June 1, 2022
Z-0053-2021Class IIPermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methAugust 31, 2020
Z-0690-2019Class IIEnamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast July 12, 2018
Z-3214-2017Class IIUltradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product UsAugust 4, 2017
Z-3217-2017Class IIUltradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product UsAugust 4, 2017
Z-3216-2017Class IIUltradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product UAugust 4, 2017
Z-3215-2017Class IIUltradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product UAugust 4, 2017
Z-3218-2017Class IIUltradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product UAugust 4, 2017
Z-1034-2017Class IINanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips tDecember 14, 2016
Z-0704-2017Class IIUltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage:November 17, 2016
Z-0583-2016Class IIInterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 PrDecember 22, 2015
Z-0481-2014Class IIIOpal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets aNovember 19, 2013
F-1271-2013Class IIIOpalescence Treswhite Supreme Peach Patient KitMarch 8, 2013
Z-0876-2013Class IIIAvex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets aFebruary 8, 2013
Z-0812-2013Class IIIUltradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression MaterFebruary 4, 2013
Z-0811-2013Class IIIUltradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression MaFebruary 4, 2013
F-1710-2012Class IISpearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces June 18, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K240743Peak Universal BondMarch 20, 2024
K240694FORMA Composite (Shade A3D)March 15, 2024
K221909J-TempJuly 1, 2022
K220471VALO X, VALO X Accessory LensesFebruary 22, 2022
K211905UltraCal XSOctober 13, 2021
K211237UltraTemp Rez IIJuly 13, 2021
K210550VALO Grand Corded and Accessory LensesMarch 1, 2021
K190627VALO Grand CordedApril 29, 2019
K173163ChlorCid, ChlorCid V, ChlorCid SurfFebruary 9, 2018
K160551VALO GrandJuly 13, 2016
K152064Astringedent ClearSeptember 24, 2015
K151094Mosaic Universal CompositeJuly 21, 2015
K131357PEAK ZSeptember 6, 2013
K123215VISCOSTAT CLEARFebruary 5, 2013
K112517ULTRASEAL XT HYDROSeptember 23, 2011
K111836PERMASHADE VENEER CEMENTSeptember 16, 2011
K111696OPAL BAND CEMENTSeptember 7, 2011
K111017CLEARTEMPJune 6, 2011
K110582VALO CORDLESSApril 28, 2011
K101245ULTRASEAL IDSeptember 17, 2010