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FDA 510(k)

Steri-Cassette and Steri-Cage Sterilization Packaging System

K-Number: K162063 · 2017-04-21

ApplicantSybron Dental Specialties
Decision Date2017-04-21
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steri-Cassette and Steri-Cage Sterilization Packaging System is a medical device manufactured by Sybron Dental Specialties. It received FDA 510(k) clearance on 2017-04-21 under approval number K162063. 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 Steri-Cassette and Steri-Cage Sterilization Packaging System?

Steri-Cassette and Steri-Cage Sterilization Packaging System is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Sybron Dental Specialties. The 510(k) number is K162063.

When was Steri-Cassette and Steri-Cage Sterilization Packaging System approved by the FDA?

Steri-Cassette and Steri-Cage Sterilization Packaging System received FDA 510(k) clearance on 2017-04-21, under approval number K162063.

What company makes Steri-Cassette and Steri-Cage Sterilization Packaging System?

Steri-Cassette and Steri-Cage Sterilization Packaging System is manufactured by Sybron Dental Specialties.

What is the FDA product code for Steri-Cassette and Steri-Cage Sterilization Packaging System?

The FDA product code for Steri-Cassette and Steri-Cage Sterilization Packaging System is KCT.

Related Clinical Trials

NCT01757665 ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE) COMPLETED NCT04610294 Operating Room Air Filtration/Sterilization ACTIVE_NOT_RECRUITING

Other Devices by Sybron Dental Specialties

K160097Image Fast Set, Image Regular Set K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress K152956Pulp Canal Sealer, Pulp Canal Sealer EWT K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes K182826Ormco Spark Aligner System

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, 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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