Medical Device Manufacturer · CN , Changsha High-Tech Development Zone Chan

Enpuno Biotechnology Co., Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2024

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Enpuno Biotechnology Co., Ltd. Dental ✕

2 devices

1-2 of 2

Cleared Sep 25, 2025

Root canal repair materials (nRoot BP)

Cleared May 28, 2024

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR...