PlainRecalls

Ultradent Products, Inc.

Compiled from official public sources by the publisher.

24 recalls on record · Latest: Apr 8, 2026

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Agency notice ledger

Federal filing book Ultradent Products, Inc. MID-BOOK · MULTI-AGENCY

#693 of 14,151 · 24 notices · 0.023% archive

  • BOOK 24 notices
  • RANK #693 of 14,151
  • SHARE 0.023% archive
  • AGENCY FDA Devices (20)
  • CAT medical devices
  • CATS 3 categories
  • LATEST Apr 8, 2026
  • PHOTO Bio-Rad Laboratories,…

Nearest notice-volume peer: Bio-Rad Laboratories, Inc. (0 notice gap)

Ultradent Products, Inc. accounts for about 0.023% of the 104,423-notice archive on 24 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Ultradent Products, Inc.'s standing among 14,151 recalling firms

Ultradent Products, Inc. ranks 693rd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Ultradent Products, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

24 693rd of 14151 higher than 13,456 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Ultradent Products, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Ultradent Products, Inc. holds about 0.023% of archive notices alongside 24 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026

How the 24 notices break down

Same federal filing book as the hero total — split by issuing agency, no new counts.

FDA Devices Moderate Apr 8, 2026

Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
FDA Devices Moderate Sep 18, 2024

Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by v
FDA Devices Moderate Sep 18, 2024

Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has a
FDA Devices Moderate Sep 18, 2024

Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 ¿m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available

FDA Devices Moderate Jul 20, 2022

Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
FDA Devices Moderate Oct 14, 2020

PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
FDA Devices Moderate Jan 9, 2019

Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Manufactured by Ultradent Products Inc. ****Label Enamelast Unit Dose 200pk Variety Pack - The Variety Pack (PN#4368) includes f
FDA Devices Moderate Oct 4, 2017

Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
FDA Devices Moderate Oct 4, 2017

Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
FDA Devices Moderate Oct 4, 2017

Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
FDA Devices Moderate Oct 4, 2017

Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
FDA Devices Moderate Oct 4, 2017

Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
FDA Devices Moderate Jan 25, 2017

NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide

FDA Devices Moderate Dec 14, 2016

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.
FDA Devices Moderate Jan 13, 2016

InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.
FDA Devices Low Dec 18, 2013

Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
FDA Food Low Apr 3, 2013

Opalescence Treswhite Supreme Peach Patient Kit
FDA Devices Low Mar 6, 2013

Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
FDA Devices Low Feb 20, 2013

Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
FDA Devices Low Feb 20, 2013

Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
FDA Food Moderate Jul 11, 2012

Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.
FDA Food Moderate Jul 11, 2012

Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8418.
FDA Food Moderate Jul 11, 2012

Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.
FDA Devices Moderate Jun 27, 2012

Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cu

Ultradent Products, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms that share this firm's dominant product category.

Bio-Rad Laboratories, Inc. 24 Biomet 24 Boston Scientific Neuromodulation Corporation 24 Church & Dwight Inc 24

Frequently Asked Questions

How many federal recall notices name Ultradent Products, Inc.? ▼
PlainRecalls indexes 24 distinct federal recall events naming Ultradent Products, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Ultradent Products, Inc. sit among other recalling firms? ▼
Ultradent Products, Inc. ranks #693 of 14,151 by distinct recall-event count among 14,151 firms in this archive (95th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Ultradent Products, Inc.'s notices? ▼
FDA Devices accounts for 20 of this firm's 24 indexed notices across 2 issuing agencies.
What product category dominates Ultradent Products, Inc.'s filing book? ▼
Filings for Ultradent Products, Inc. span 3 product categories, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Ultradent Products, Inc.: 24 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Ultradent Products, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026