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FDA 510(k)

ENDODONTIC ROOT CANAL PLUGGER

K-Number: K860569 · 1986-03-26

ApplicantDentsply Intl.
Decision Date1986-03-26
Product CodeEKR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDODONTIC ROOT CANAL PLUGGER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1986-03-26 under 510(k) number K860569. The device is classified under product code EKR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDODONTIC ROOT CANAL PLUGGER?

ENDODONTIC ROOT CANAL PLUGGER is a medical device that received FDA 510(k) clearance on 1986-03-26. The listed applicant is Dentsply Intl.. The 510(k) number is K860569.

When did ENDODONTIC ROOT CANAL PLUGGER receive FDA 510(k) clearance?

ENDODONTIC ROOT CANAL PLUGGER received FDA 510(k) clearance on 1986-03-26, under 510(k) number K860569.

Who is the listed applicant for ENDODONTIC ROOT CANAL PLUGGER?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDODONTIC ROOT CANAL PLUGGER?

The FDA product code for ENDODONTIC ROOT CANAL PLUGGER is EKR.

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Related Devices (Code: EKR)

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.

K060347B&L L-BETA, MODEL WL-B1B&L Biotech Co., Ltd.K042828OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700Young O/S, LLCK031664ELEMENTS OBTURATION UNITSybron Endo/AnalyticK831748ENDODONTIC ROOT CANAL PLUGGER FINGER-Union BranchK791019MCSPADDEN CONDENSORTechdent, 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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