Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth Recalled by Envisiontec US Llc Due to Mislabeling

Date: January 6, 2022
Company: Envisiontec US Llc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Envisiontec US Llc directly.

Affected Products

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

Quantity: 795 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Envisiontec US Llc

Envisiontec US Llc has 3 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report