The Recall Desk
HighFDA (Devices)·Z-0642-2022·Announced 2022-02-23

Dental Resin Product Recalled Due to Non-Registered Manufacturing and Mislabeling

Envisiontec US Llc recalls FLEXCERA BASE dental resin (574 units manufactured April–September 2021) due to manufacturing in a non-FDA-registered facility and mislabeling of country of origin.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a product used in the oral cavity, manufactured in a non-FDA-registered facility (quality control risk), with mislabeling of country of origin. No reported illnesses or injuries, but manufacturing non-compliance represents a risk of harm through inadequate facility oversight.

Plain-English summary

Envisiontec US Llc is recalling FLEXCERA BASE, a dental resin used for the fabrication of artificial teeth. The recall involves 574 units manufactured between April 1, 2021 and September 15, 2021, with distribution nationwide in the United States.

The product is being recalled because it was manufactured in a facility that is not registered with the FDA and was mislabeled as being of German origin.

The recalled product

Product
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
Manufacturer
Envisiontec US Llc
Category
Medical Device — Dental Resin Material
Hazard
  • unregistered-facility
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Manufactured from April 1
  • 2021 to September 15

Distribution

Distributed nationwide across the United States.

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