Guided Surgery Kit— 510(k) K231087

Name: FDA 510(k) clearance K231087
Creator: U.S. Food and Drug Administration
Published: 2023-08-16

Substantially Equivalent

Implant Direct Sybron Manufacturing, LLC

FDA 510(k) clearance K231087 for Guided Surgery Kit, Substantially Equivalent on 2023-08-16. Applicant: Implant Direct Sybron Manufacturing, LLC. Device class: 2.

Clearance details

Applicant: Implant Direct Sybron Manufacturing, LLC
Product code: Code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2023-04-17
Decision date: 2023-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.