Z-0746-2022Class II

PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and...

Name: Z-0746-2022 PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and...
Creator: Envisiontec US Llc
Published: 2022-01-20
License: https://open.fda.gov/license/

Envisiontec US LLC / initiated 2022-01-20 / Open, Classified

FDA source

Envisiontec US Llc began a recall of 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... on 2022-01-20. FDA classified it as Class II and gives the reason as "The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0746-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-20
Posted: 2022-03-10
Recalling firm: Envisiontec US LLC
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.
Product code: EBZ Activator, Ultraviolet, For Polymerization
Reason for recall: The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
FDA root cause: Unknown/Undetermined by firm
Action: The firm, Evisiontec US LLC., sent "URGENT: PRODUCT RECALL" notification letters dated 1/20/22 to customers. ACTION: 1. Stop utilizing the PCA 4000 to print medical devices made from EnvisionTec dental resins. 2. Please carry out a physical count and record this data on the Recall Response Form included with this letter. 3. Submit the Recall Response Form by e-mail: [email protected] or fax to: 866-875-0545 even if you do not have the recalled product. 4. Contact EnvisionTec customer service at envisiontec.com/support to arrange for the return and replacement of the recalled product. This recall is being carried out only for the specific products identified above; no other products are involved in this recall. Notifications of this recall are being sent to all accounts to whom EnvisionToc shipped a recalled product. For customers that redistribute this product to other accounts, please notify your accounts. For questions about the recall process please contact Sedgwick at 1-866-512-4073. For other inquiries regarding these products and to initiate your return, please contact Envision Tac customer service at envisiontec.com/support (if you do not have access to the Internet, contact Sedgwick at the toll-free number above with your contact information and EnvisionTec customer service will promptly contact you to arrange your return). A replacement curing unit of equal or greater value will be provided to customers; if replacement is not available, a credit will be issued to customers at the price in effect at the time of purchase.
Quantity in commerce: 172 units
Distribution: US Nationwide
Product codes and lots: All units SKU number ACC-06-1000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0746-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0746-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-10

Product code EBZ

K201173UnclassifiedE-GuardEnvisiontec GmbH / cleared 2020-11-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)