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FDA 510(k)

ROOT CANAL FILES, TYPE K

K-Number: K822621 · 1982-09-28

ApplicantUnion Broach, Div. Moyco Industries, Inc.
Decision Date1982-09-28
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOT CANAL FILES, TYPE K 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 1982-09-28 under 510(k) number K822621. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOT CANAL FILES, TYPE K?

ROOT CANAL FILES, TYPE K is a medical device that received FDA 510(k) clearance on 1982-09-28. The listed applicant is Union Broach, Div. Moyco Industries, Inc.. The 510(k) number is K822621.

When did ROOT CANAL FILES, TYPE K receive FDA 510(k) clearance?

ROOT CANAL FILES, TYPE K received FDA 510(k) clearance on 1982-09-28, under 510(k) number K822621.

Who is the listed applicant for ROOT CANAL FILES, TYPE K?

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 ROOT CANAL FILES, TYPE K?

The FDA product code for ROOT CANAL FILES, TYPE K is EKS.

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

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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: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, 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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