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FDA 510(k)

ENDODONTIC BROACH(76EKN) BARBED BROACH

K-Number: K831749 · 1983-07-12

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

Device Summary

ENDODONTIC BROACH(76EKN) BARBED BROACH 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 K831749. The device is classified under product code EKW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDODONTIC BROACH(76EKN) BARBED BROACH?

ENDODONTIC BROACH(76EKN) BARBED BROACH 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 K831749.

When did ENDODONTIC BROACH(76EKN) BARBED BROACH receive FDA 510(k) clearance?

ENDODONTIC BROACH(76EKN) BARBED BROACH received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831749.

Who is the listed applicant for ENDODONTIC BROACH(76EKN) BARBED BROACH?

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 BROACH(76EKN) BARBED BROACH?

The FDA product code for ENDODONTIC BROACH(76EKN) BARBED BROACH is EKW.

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.

K831748ENDODONTIC ROOT CANAL PLUGGER FINGER-

Related Devices (Code: EKW)

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.

K871493DENTI-TRAY(TM)Advanced Medical, Inc.K870765CANNULATED INSTRUMENT CLEANERSTreace Medical, Inc.K862523MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYSWalter Lorenz Surgical, Inc.K823489ENDODONTIC BROACH-BARBED BROACHUnion Broach, Div. Moyco Industries, Inc.K800292ENDEX BROACH, ENDODONTICIpco Corp.K760985HAND INSTRUMENTSAdp Intl., 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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