Keystone Industries
Keystone Industries holds FDA 510(k) medical device clearances, first cleared 2019, most recent 2025, with 3 FDA device recalls on record.
Top product codes for Keystone Industries
FDA recalls by Keystone Industries
- Z-0630-2024 — KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
- Z-2579-2023 — 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 No. 0921526
- Z-2580-2023 — Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Keystone Industries
Data sourced from openFDA. This site is unofficial and independent of the FDA.