# FDA recall Z-0643-2022

> **Envisiontec US Llc** · Class II · device recall initiated 2022-01-06.

## Product

FLEXCERA SMILE  -a Dental resins for the fabrication of artificial teeth

## Reason for recall

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0643-2022
- **Recalling firm:** Envisiontec US Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-06
- **Report date:** 2022-02-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dearborn, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0643-2022

## Citation

> AI Analytics. FDA recall Z-0643-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0643-2022. Source: US FDA. Licensed CC0.

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