NobelZygoma PureSet Tray— 510(k) K231219

Name: FDA 510(k) clearance K231219
Creator: U.S. Food and Drug Administration
Published: 2023-06-27

Substantially Equivalent

Nobel Biocare Services AG

FDA 510(k) clearance K231219 for NobelZygoma PureSet Tray, Substantially Equivalent on 2023-06-27. Applicant: Nobel Biocare Services AG. Device class: 2.

Clearance details

Applicant: Nobel Biocare Services AG
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2023-04-28
Decision date: 2023-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kloten, CH

Download summary PDF View on FDA.gov ↗

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