The Recall Desk

Manufacturer

Envisiontec US Llc

3 recalls in our database name Envisiontec US Llc as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2022-03-16

Of the 3 recalls from Envisiontec US Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-0746-2022·2022-03-16

    PCA 4000 Dental Curing Units May Not Fully Cure Resins

    Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).

    Product
    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0642-2022·2022-02-23

    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.

    Product
    FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0643-2022·2022-02-23

    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.

    Product
    FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
    Category
    Medical Device
    Distribution
    Distributed nationwide