# FDA recall Z-0053-2021

> **Ultradent Products, Inc.** · Class II · device recall initiated 2020-08-31.

## Product

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.

## Reason for recall

Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

## 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.

## Key facts

- **Recall number:** Z-0053-2021
- **Recalling firm:** Ultradent Products, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-31
- **Report date:** 2020-10-14
- **Termination date:** 2021-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2021

## Citation

> AI Analytics. FDA recall Z-0053-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0053-2021. Source: US FDA. Licensed CC0.

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