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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 a medical device manufactured by Pac-Dent, Inc.. It received FDA 510(k) clearance on 2020-07-06 under approval 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. It is manufactured by Pac-Dent, Inc.. The 510(k) number is K200330.

When was RC-Prime Root Canal Preparation Cream approved by the FDA?

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

What company makes RC-Prime Root Canal Preparation Cream?

RC-Prime Root Canal Preparation Cream is manufactured by Pac-Dent, Inc..

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.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07526844 Effect of Instrumentation Systems and Sealers on Postoperative Pain NOT_YET_RECRUITING

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Related Devices (Code: KJJ)

K160577PacEndo ChlorhexidinePac-Dent International, Inc. K153528PacEndo EDTAPac-Dent International, Inc. K162311Straumann PrefGelInstitut Straumann AG K173163ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc. K193357V-MixInter-Med/Vista Dental Products K193409Vista 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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