K-number	K251465
Device name	Root canal repair materials (nRoot BP)
Applicant	Enpuno Biotechnology Co., Ltd.
Product code	KIF
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	872.3820

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

nRoot BP is a root canal repair material designed for permanent root canal sealing and repair in endodontic and surgical applications. It is indicated for root perforation repair, root resorption repair, root end filling, apexification, and pulp capping procedures.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Root canal repair materials (nRoot BP)

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