DeviceClearance

Duranext Abutments— 510(k) K200355

Substantially Equivalent

Elegant Dental Corp.

FDA 510(k) clearance K200355 for Duranext Abutments, Substantially Equivalent on 2020-07-22. Applicant: Elegant Dental Corp.. Device class: 2.

Clearance details

Applicant
Elegant Dental Corp.
Product code
Code NHA
Device class
Class 2
Regulation
21 CFR 872.3630
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brooklyn, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code NHA

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Adverse events under product code NHA

product code NHA
Injury
1,270
Malfunction
2,860
Total
4,130

Source: openFDA MAUDE database, through . 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.