Enamel Pure is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Enamel Pure - FDA 510(k) Cleared Devices
Recent clearances: LUNE PureHygiene, LUNE™ PureHygiene
2
Total
2
Cleared
0
Denied
Enamel Pure has 2 FDA 510(k) cleared medical devices. Based in Worcester, US.
Latest FDA clearance: May 2026. Active since 2024. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Enamel Pure Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Omnee Strategic Solutions, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Enamel Pure
2 devices