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FDA 510(k)

STERILE DENTAL KITS

K-Number: K923902 · 1993-06-29

ApplicantProfessional Sterile Systems, Inc.
Decision Date1993-06-29
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERILE DENTAL KITS is the device name listed in this FDA 510(k) record. The listed applicant is Professional Sterile Systems, Inc.. It received FDA 510(k) clearance on 1993-06-29 under 510(k) number K923902. 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 STERILE DENTAL KITS?

STERILE DENTAL KITS is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is Professional Sterile Systems, Inc.. The 510(k) number is K923902.

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

STERILE DENTAL KITS received FDA 510(k) clearance on 1993-06-29, under 510(k) number K923902.

Who is the listed applicant for STERILE DENTAL KITS?

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

What is the FDA product code for STERILE DENTAL KITS?

The FDA product code for STERILE DENTAL KITS 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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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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