Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)— 510(k) K240304

Substantially Equivalent

Enpuno Biotechnology Co., Ltd.

FDA 510(k) clearance K240304 for Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5), Substantially Equivalent on 2024-05-28. Applicant: Enpuno Biotechnology Co., Ltd..

Clearance details

Applicant: Enpuno Biotechnology Co., Ltd.
Product code: Code KIF
Advisory panel: Dental
Date received: 2024-02-02
Decision date: 2024-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha High-Tech Development Zone Chan, CN

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