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FDA 510(k)

SOUTHLAND STERILE DENTAL SYSTEM

K-Number: K935127 · 1994-07-28

ApplicantSouthland, Ltd.
Decision Date1994-07-28
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOUTHLAND STERILE DENTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Southland, Ltd.. It received FDA 510(k) clearance on 1994-07-28 under 510(k) number K935127. 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 SOUTHLAND STERILE DENTAL SYSTEM?

SOUTHLAND STERILE DENTAL SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is Southland, Ltd.. The 510(k) number is K935127.

When did SOUTHLAND STERILE DENTAL SYSTEM receive FDA 510(k) clearance?

SOUTHLAND STERILE DENTAL SYSTEM received FDA 510(k) clearance on 1994-07-28, under 510(k) number K935127.

Who is the listed applicant for SOUTHLAND STERILE DENTAL SYSTEM?

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

What is the FDA product code for SOUTHLAND STERILE DENTAL SYSTEM?

The FDA product code for SOUTHLAND STERILE DENTAL SYSTEM 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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