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FDA 510(k)

ENDODONTIC ROOT CANAL PLUGGER FINGER-

K-Number: K831748 · 1983-07-12

ApplicantUnion Branch
Decision Date1983-07-12
Product CodeEKR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDODONTIC ROOT CANAL PLUGGER FINGER- is the device name listed in this FDA 510(k) record. The listed applicant is Union Branch. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831748. 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 FINGER-?

ENDODONTIC ROOT CANAL PLUGGER FINGER- is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Union Branch. The 510(k) number is K831748.

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

ENDODONTIC ROOT CANAL PLUGGER FINGER- received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831748.

Who is the listed applicant for ENDODONTIC ROOT CANAL PLUGGER FINGER-?

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

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

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Union Branch as applicant

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.

K831749ENDODONTIC BROACH(76EKN) BARBED BROACH

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/AnalyticK860569ENDODONTIC ROOT CANAL PLUGGERDentsply Intl.K791019MCSPADDEN 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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