FDA Device recall Z-0746-2022
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 uni…
- FDA Device
- Class II
- ongoing
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II 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 uni… by Envisiontec Us, citing the PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0746-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-20 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Envisiontec Us |
| Distribution | US |
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.
Identifiers
| code_info | All units SKU number ACC-06-1000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0746-2022%22
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