510(k) K201173 ยท MQC Mouthguard, Prescription
E-Guard
| Applicant | Envisiontec GmbH, Gladbeck, DE |
| Decision | Substantially Equivalent, Nov 27, 2020 |
| Received | May 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2022 | Envisiontec US Llc 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. Open, Classified |
EBZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.