The Recall Desk
ModerateFDA (Devices)·Z-0643-2022·Announced 2022-02-23

Dental Resins Recalled for Manufacturing Facility and Origin Labeling Violations

Envisiontec US LLC recalled 795 units of FLEXCERA SMILE dental resins manufactured between April 2021 and September 2021 because they were produced in a non-FDA-registered facility and falsely labeled as German origin.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazards are regulatory compliance violations (non-FDA-registered manufacturing facility) and labeling misrepresentation, not documented product-performance defects.

Plain-English summary

FLEXCERA SMILE is a dental resin used to fabricate artificial teeth. The recall affects 795 units manufactured by Envisiontec US LLC between April 1, 2021 and September 15, 2021, distributed nationwide in the United States.

The products were manufactured in a facility not registered with the FDA and were mislabeled as being of German origin, representing failures in regulatory compliance and truthful labeling.

No illnesses or injuries have been reported. Consumers in possession of affected units should discontinue use and contact the manufacturer or their dental supplier for return or replacement instructions.

The recalled product

Product
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Manufacturer
Envisiontec US Llc
Category
Medical Device — Dental / Restorative
Hazard
  • manufacturing-compliance
  • false-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.

Related recalls

Same category