510(k) K183598 ยท MQC Mouthguard, Prescription
KeyPrint KeySplint Soft
| Applicant | Keystone Industries, Gibbstown NJ, US |
| Decision | Substantially Equivalent, Nov 15, 2019 |
| Received | Dec 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2021 | Straumann USA LLC KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.
Model (Ref) #: 4220005 Open, Classified |
MQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.