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FDA 510(k)

SANI-PIKS DENTAL HAND INSTRUMENT

K-Number: K895985 · 1990-01-10

ApplicantBison-Lee Co.
Decision Date1990-01-10
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SANI-PIKS DENTAL HAND INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Bison-Lee Co.. It received FDA 510(k) clearance on 1990-01-10 under 510(k) number K895985. 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 SANI-PIKS DENTAL HAND INSTRUMENT?

SANI-PIKS DENTAL HAND INSTRUMENT is a medical device that received FDA 510(k) clearance on 1990-01-10. The listed applicant is Bison-Lee Co.. The 510(k) number is K895985.

When did SANI-PIKS DENTAL HAND INSTRUMENT receive FDA 510(k) clearance?

SANI-PIKS DENTAL HAND INSTRUMENT received FDA 510(k) clearance on 1990-01-10, under 510(k) number K895985.

Who is the listed applicant for SANI-PIKS DENTAL HAND INSTRUMENT?

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

What is the FDA product code for SANI-PIKS DENTAL HAND INSTRUMENT?

The FDA product code for SANI-PIKS DENTAL HAND INSTRUMENT is EKJ.

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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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