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FDA 510(k)

NobelZygoma PureSet™ Tray

K-Number: K231219 · 2023-06-27

ApplicantNobel Biocare Services AG
Decision Date2023-06-27
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NobelZygoma PureSet™ Tray is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2023-06-27 under 510(k) 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. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K231219.

When did NobelZygoma PureSet™ Tray receive FDA 510(k) clearance?

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

Who is the listed applicant for NobelZygoma PureSet™ Tray?

The FDA 510(k) record lists Nobel Biocare Services AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NobelZygoma PureSet™ Tray?

The FDA product code for NobelZygoma PureSet™ Tray is KCT.

Other records listing Nobel Biocare Services AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220339Esthetic Abutments Nobel Biocare N1K220048NobelProcera Zirconia N1 BaseK211109N1 TiUltra TCC Implant SystemK212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

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