510(k) K203000 ยท MQC Mouthguard, Prescription
KeyPrint KeySplint Hard
| Applicant | Mycone Dental Supply Co. Inc. (Dba Keystone Industries), Gibbstown NJ, US |
| Decision | Substantially Equivalent, Apr 9, 2021 |
| Received | Oct 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203000
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2024 | Keystone Industries KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental
appliances such as mouthguards, nightguards, splints, repositioners, and retainers
Item No.: 4220011 Open, Classified |
MQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.