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FDA 510(k)

DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE

K-Number: K962545 · 1997-03-07

ApplicantSterilization Cassette Systems, Inc.
Decision Date1997-03-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Sterilization Cassette Systems, Inc.. It received FDA 510(k) clearance on 1997-03-07 under 510(k) number K962545. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE?

DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE is a medical device that received FDA 510(k) clearance on 1997-03-07. The listed applicant is Sterilization Cassette Systems, Inc.. The 510(k) number is K962545.

When did DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE receive FDA 510(k) clearance?

DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE received FDA 510(k) clearance on 1997-03-07, under 510(k) number K962545.

Who is the listed applicant for DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE?

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

What is the FDA product code for DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE?

The FDA product code for DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE is KCT.

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Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, 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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