K-number	K250279
Device name	RC-SwiftPrep
Applicant	Belport Company, Inc., Gingi-Pak
Product code	KJJ
Device class	Class U
Decision date	Jul 2, 2025
Decision	Substantially Equivalent
Regulation	—

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

RC-SwiftPrep is a root canal cleanser gel designed to etch, cleanse, and debride root canal walls while removing smear layers prior to obturation. It facilitates efficient instrumentation and promotes optimal sealing of the canal.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

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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RC-SwiftPrep

Everything you need for a 510(k) submission. Nothing you don't.