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FDA 510(k)

MAUNAL DISPOSABLE DENTAL INSTRUMENTS

K-Number: K943351 · 1994-10-07

ApplicantMagnum Instruments, Inc.
Decision Date1994-10-07
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAUNAL DISPOSABLE DENTAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Magnum Instruments, Inc.. It received FDA 510(k) clearance on 1994-10-07 under 510(k) number K943351. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAUNAL DISPOSABLE DENTAL INSTRUMENTS?

MAUNAL DISPOSABLE DENTAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Magnum Instruments, Inc.. The 510(k) number is K943351.

When did MAUNAL DISPOSABLE DENTAL INSTRUMENTS receive FDA 510(k) clearance?

MAUNAL DISPOSABLE DENTAL INSTRUMENTS received FDA 510(k) clearance on 1994-10-07, under 510(k) number K943351.

Who is the listed applicant for MAUNAL DISPOSABLE DENTAL INSTRUMENTS?

The FDA 510(k) record lists Magnum Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAUNAL DISPOSABLE DENTAL INSTRUMENTS?

The FDA product code for MAUNAL DISPOSABLE DENTAL INSTRUMENTS is EKJ.

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.

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Other records listing Magnum Instruments, 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.

K943820STAT PAK

Related Devices (Code: EKJ)

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.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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