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FDA 510(k)

ENDODONTIC BROACH-BARBED BROACH

K-Number: K823489 · 1982-12-15

ApplicantUnion Broach, Div. Moyco Industries, Inc.
Decision Date1982-12-15
Product CodeEKW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDODONTIC BROACH-BARBED BROACH is the device name listed in this FDA 510(k) record. The listed applicant is Union Broach, Div. Moyco Industries, Inc.. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K823489. 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-BARBED BROACH?

ENDODONTIC BROACH-BARBED BROACH is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Union Broach, Div. Moyco Industries, Inc.. The 510(k) number is K823489.

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

ENDODONTIC BROACH-BARBED BROACH received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823489.

Who is the listed applicant for ENDODONTIC BROACH-BARBED BROACH?

The FDA 510(k) record lists Union Broach, Div. Moyco Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDODONTIC BROACH-BARBED BROACH?

The FDA product code for ENDODONTIC BROACH-BARBED BROACH is EKW.

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Other records listing Union Broach, Div. Moyco Industries, Inc. 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.

K962733CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)K950365MOYCO-EDTAK941574RETRO MIRRORK940260THERMAL PULP TESTERK935542NICKEL-TITANIUM K-TYPE FILEK931742INJECT-R FILL

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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.K831749ENDODONTIC BROACH(76EKN) BARBED BROACHUnion BranchK800292ENDEX 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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