510(k) K231144

Washtrays by Dentsply Sirona — Product Code KCT

K231144 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Washtrays". The FDA issued a decision of Substantially Equivalent on January 16, 2024. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Dentsply Sirona has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2024
Date Received
April 21, 2023
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