Reported Sep 18, 2024 · Ongoing
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757-…
Ultradent Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3800
Is this the product you have?
- Brand NameTranscend
- Product NameTranscend Singles Universal Body (UB)
- Refill 10pk Model/Catalog Number4757-
- Software VersionN/A
- Product DescriptionTranscend 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 an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution
- ComponentN/A
- Lot codes and dates
- Lot Code
Model No 4757UDI-DI 00883205028334Lot Number C15C2Expiration Date 31-May-2026
- Lot Code
- Amount recalled
- 2450
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to a manufacturing issue, red particulates present in the expressed composite.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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