510(k) K163600

Kit Boxes and Kit Plates by Nobel Biocare AB — Product Code KCT

K163600 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "Kit Boxes and Kit Plates". The FDA issued a decision of Substantially Equivalent on Jan 22, 2018. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Nobel Biocare AB has 95 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 22, 2018
Date Received
Dec 21, 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
510(k)