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FDA 510(k)

FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE

K-Number: K855136 · 1986-03-06

ApplicantUnion Broach, Div. Moyco Industries, Inc.
Decision Date1986-03-06
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE 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 1986-03-06 under 510(k) number K855136. 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 FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE?

FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Union Broach, Div. Moyco Industries, Inc.. The 510(k) number is K855136.

When did FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE receive FDA 510(k) clearance?

FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE received FDA 510(k) clearance on 1986-03-06, under 510(k) number K855136.

Who is the listed applicant for FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE?

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 FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE?

The FDA product code for FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE is EKS.

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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.

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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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