Medical Device Manufacturer · US , Clarksville , TN

Enamelite, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2003

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Enamelite, LLC Dental ✕

2 devices

1-2 of 2

Cleared Dec 22, 2009

ENAMELITE ACRYSEAL SPRAY SEALANT

Cleared Mar 27, 2003

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 28, 2026