FDA 510(k)

NobelZygoma PureSet Tray

K-Number: K231219 · 2023-06-27

Decision Date2023-06-27

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NobelZygoma PureSet Tray is a medical device manufactured by Nobel Biocare Services AG. It received FDA 510(k) clearance on 2023-06-27 under approval number K231219. 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 NobelZygoma PureSet Tray?

NobelZygoma PureSet Tray is a medical device that received FDA 510(k) clearance on 2023-06-27. It is manufactured by Nobel Biocare Services AG. The 510(k) number is K231219.

When was NobelZygoma PureSet Tray approved by the FDA?

NobelZygoma PureSet Tray received FDA 510(k) clearance on 2023-06-27, under approval number K231219.

What company makes NobelZygoma PureSet Tray?

NobelZygoma PureSet Tray is manufactured by Nobel Biocare Services AG.

What is the FDA product code for NobelZygoma PureSet Tray?

The FDA product code for NobelZygoma PureSet Tray is KCT.

Other Devices by Nobel Biocare Services AG

K211109N1 TiUltra TCC Implant System K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray K220339Esthetic Abutments Nobel Biocare N1 K220048NobelProcera Zirconia N1 Base

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Official Source

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