Cleared Traditional

Kit Boxes and Kit Plates

K163600 · Nobel Biocare AB · General Hospital

Jan 2018

Decision

397d

Days

Class 2

Risk

About This 510(k) Submission

K163600 is an FDA 510(k) clearance for the Kit Boxes and Kit Plates, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on January 22, 2018, 397 days after receiving the submission on December 21, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K163600 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2016
Decision Date	January 22, 2018
Days to Decision	397 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850