Company ยท US
Keystone Industries
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| 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 | K203000 |
| Sep 12, 2023 | Keystone Industries Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material
KI Item No.: 0921940HS
Henry Schein Item No.: 570-0718 Open, Classified |
EBI | None listed |
| Sep 12, 2023 | Keystone Industries Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina
Item Open, Classified |
LBH | K933505 |