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
- Affected units
- 574
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.
Part of a larger recall action
This product is one of 2 recalled by Envisiontec US Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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