FDA 510(k)

PureSet Tray

K-Number: K181075 · 2018-09-27

Decision Date2018-09-27

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PureSet Tray is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2018-09-27 under approval number K181075. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PureSet Tray?

PureSet Tray is a medical device that received FDA 510(k) clearance on 2018-09-27. It is manufactured by Nobel Biocare AB. The 510(k) number is K181075.

When was PureSet Tray approved by the FDA?

PureSet Tray received FDA 510(k) clearance on 2018-09-27, under approval number K181075.

What company makes PureSet Tray?

PureSet Tray is manufactured by Nobel Biocare AB.

What is the FDA product code for PureSet Tray?

The FDA product code for PureSet Tray is KCT.

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Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.