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FDA 510(k)

DENTAL HAND INSTRUMENTS

K-Number: K874964 · 1988-01-27

ApplicantSolway, Inc.
Decision Date1988-01-27
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL HAND INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Solway, Inc.. It received FDA 510(k) clearance on 1988-01-27 under 510(k) number K874964. 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 DENTAL HAND INSTRUMENTS?

DENTAL HAND INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1988-01-27. The listed applicant is Solway, Inc.. The 510(k) number is K874964.

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

DENTAL HAND INSTRUMENTS received FDA 510(k) clearance on 1988-01-27, under 510(k) number K874964.

Who is the listed applicant for DENTAL HAND INSTRUMENTS?

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

What is the FDA product code for DENTAL HAND INSTRUMENTS?

The FDA product code for DENTAL HAND INSTRUMENTS is EKJ.

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Other records listing Solway, 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.

K874960CARDIOVASCULAR SURGICAL INSTRUMENTSK874962FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULASK874956SELF-RETAINING RETRACTOR FOR NEUROSURGERYK875043RONGEUR (NEUROSURGICAL INSTRUMENTS)K874966TUNING FORKSK874950MICROSURGICAL INSTRUMENTS

View all 13 devices →

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

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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