Recall Z-0746-2022— Envisiontec US Llc

Name: FDA recall Z-0746-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-20

Class II · Ongoing

Class II FDA medical device recall by Envisiontec US Llc, initiated 2022-01-20. It names one FDA 510(k) clearance: K201173. 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.. Reason: The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications..

Recalling firm: Envisiontec US Llc
Classification: Class II
Status: Ongoing
Initiated: 2022-01-20
Firm location: Dearborn, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K201173 — E-GuardEnvisiontec GmbH·cleared 2020-11-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

Data sourced from openFDA. This site is unofficial and independent of the FDA.