PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product… recallZ-0053-2021 · Ultradent Products, Inc. · initiated Aug 31, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ultradent Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
FDA root cause category: Under Investigation by firm
What the company is doing
On August 31, 2020, the firm sent an URGENT FIRST NOTICE PRODUCT RECALL" notification to US customers via UPS (International customer via email on September 1, 2020) informing them of the potential product contamination that may affect the performance characteristics of the product to include, micro-hardness, bond strength, and wear and may pose an increased risk of restoration failure. Customers are instructed to discontinue use of the product immediately. Customers are also instructed to: -Complete the Return Response Form enclosed with this letter and Fax 801-553-4609 or email to [email protected]. -Using the supplied shipping labels, return to Ultradent the completed form and all unused Product; and -Maintain a ledger of the patients treated with the Product, including the patients name and applicable treatment information. The Recalling Firm will send out replacement kits and issue an $100 credit to customer's accounts For questions regarding replacement product, contact Customer Service at 1-888-230-1420. For any questions regarding the recall, contact Customer Concerns at 801-553-4139.
Recall details
- Recall number
- Z-0053-2021
- Status
- Terminated
- Initiated by the company
- Aug 31, 2020
- Recalling firm
- Ultradent Products, Inc.
- Quantity
- 412 syringes (206 kits)
- Product code
- EBF
- FDA submissions
- K974413
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.
Product description
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution.
Code information (models, lots, serial numbers)
Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PermaFlo 948Ultradent Products, Inc. · MATERIAL, TOOTH SHADE, RESIN1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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