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FDA 510(k)

RC-Prime Root Canal Preparation Cream

K-Number: K200330 · 2020-07-06

ApplicantPac-Dent, Inc.
Decision Date2020-07-06
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

RC-Prime Root Canal Preparation Cream is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2020-07-06 under 510(k) number K200330. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RC-Prime Root Canal Preparation Cream?

RC-Prime Root Canal Preparation Cream is a medical device that received FDA 510(k) clearance on 2020-07-06. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K200330.

When did RC-Prime Root Canal Preparation Cream receive FDA 510(k) clearance?

RC-Prime Root Canal Preparation Cream received FDA 510(k) clearance on 2020-07-06, under 510(k) number K200330.

Who is the listed applicant for RC-Prime Root Canal Preparation Cream?

The FDA 510(k) record lists Pac-Dent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RC-Prime Root Canal Preparation Cream?

The FDA product code for RC-Prime Root Canal Preparation Cream is KJJ.

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Other records listing Pac-Dent, Inc. 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.

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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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