Cleared Traditional

PureSet Tray

K181075 · Nobel Biocare AB · General Hospital

Sep 2018

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K181075 is an FDA 510(k) clearance for the PureSet Tray, 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 September 27, 2018, 156 days after receiving the submission on April 24, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K181075 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2018
Decision Date	September 27, 2018
Days to Decision	156 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