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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 the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties. It received FDA 510(k) clearance on 2017-04-21 under 510(k) 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. The listed applicant is Sybron Dental Specialties. The 510(k) number is K162063.

When did Steri-Cassette and Steri-Cage Sterilization Packaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for Steri-Cassette and Steri-Cage Sterilization Packaging System?

The FDA 510(k) record lists Sybron Dental Specialties as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Sybron Dental Specialties as applicant

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.

K182826Ormco Spark Aligner SystemK160097Image Fast Set, Image Regular SetK153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressK152956Pulp Canal Sealer, Pulp Canal Sealer EWTK152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

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.

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.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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