CHAIRSIDE ATTACHMENT PROCESSING MATERIAL— 510(k) K140570

Name: FDA 510(k) clearance K140570
Creator: U.S. Food and Drug Administration
Published: 2014-06-16

Substantially Equivalent

Zest Anchors, LLC

FDA 510(k) clearance K140570 for CHAIRSIDE ATTACHMENT PROCESSING MATERIAL, Substantially Equivalent on 2014-06-16. Applicant: Zest Anchors, LLC. Device class: 2.

Clearance details

Applicant: Zest Anchors, LLC
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2014-03-06
Decision date: 2014-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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