← DeviceClear
HomeDevice Clearances

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) — Enpuno Biotechnology Co., Ltd. (510(k) K

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) — Enpuno Biotechnology Co., Ltd. (510(k) K is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5); Applicant:

Device nameInjectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
ApplicantEnpuno Biotechnology Co., Ltd.
Clearance track510(k)
Submission numberK240304
DecisionSubstantially Equivalent
Decision date2024-05-28
Date received2024-02-02
Product codeKIF
Device class2
Medical specialtyDental
Applicant locationCN
SourceopenFDA device

🔍 Search all device clearances →