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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Same manufacturer · Envisiontec US Llc
See all →- HighPCA 4000 Dental Curing Units May Not Fully Cure Resins
FDA (Devices) · 2022-03-16
- ModerateDental Resins Recalled for Manufacturing Facility and Origin Labeling Violations
FDA (Devices) · 2022-02-23
Same hazard · unregistered facility
See all →- ModerateFDA Recalls Sterile Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
- HighFDA Recalls Sterile Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
- HighFDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility
FDA (Devices) · 2020-06-10
- HighFDA Recalls Sterile Custom Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
- ModerateFDA Recalls Surgical Gowns from Unregistered Facility
FDA (Devices) · 2020-06-10
Similar recalls
- HighFDA Recalls Transcend Dental Composite Material Due to Manufacturing Defect
FDA (Devices) · 2024-09-18
- HighPCA 4000 Dental Curing Units May Not Fully Cure Resins
FDA (Devices) · 2022-03-16
- SevereIce Cream Base Recalled for Undeclared Milk Allergen and Food Dyes
FDA (Food) · 2023-11-22
- HighDental Composite Resin Recall Due to Red Particulate Contamination
FDA (Devices) · 2024-09-18
- ModerateTopical Anesthetic Gel Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2024-12-25
- LowSiemens Recalls Dimension Vista IRON Flex Reagent Cartridges
FDA (Devices) · 2016-11-23