510(k) K162063

Steri-Cassette and Steri-Cage Sterilization Packaging System by Sybron Dental Specialties — Product Code KCT

K162063 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties for the device "Steri-Cassette and Steri-Cage Sterilization Packaging System". The FDA issued a decision of Substantially Equivalent on April 21, 2017. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Sybron Dental Specialties has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2017
Date Received
July 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type