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FDA 510(k)

RC-SwiftPrep

K-Number: K250279 · 2025-07-02

ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2025-07-02
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

RC-SwiftPrep is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250279. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RC-SwiftPrep?

RC-SwiftPrep is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K250279.

When did RC-SwiftPrep receive FDA 510(k) clearance?

RC-SwiftPrep received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250279.

Who is the listed applicant for RC-SwiftPrep?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RC-SwiftPrep?

The FDA product code for RC-SwiftPrep is KJJ.

Other records listing Belport Company, Inc., Gingi-Pak as applicant

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Related Devices (Code: KJJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental ProductsK200330RC-Prime Root Canal Preparation CreamPac-Dent, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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