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FDA 510(k)

FILES & REAMERS

K-Number: K812692 · 1981-10-23

ApplicantMiltex Instrument Co.
Decision Date1981-10-23
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FILES & REAMERS is the device name listed in this FDA 510(k) record. The listed applicant is Miltex Instrument Co.. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812692. 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 FILES & REAMERS?

FILES & REAMERS is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Miltex Instrument Co.. The 510(k) number is K812692.

When did FILES & REAMERS receive FDA 510(k) clearance?

FILES & REAMERS received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812692.

Who is the listed applicant for FILES & REAMERS?

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

What is the FDA product code for FILES & REAMERS?

The FDA product code for FILES & REAMERS is EKS.

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Other records listing Miltex Instrument Co. 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.

K922659GENERAL SURGERY CLAMP AND NEEDLE HOLDERK852141STERILE SURGICAL BLADESK823536INTRALIG

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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