DENRACLE DENTAL ABUTMENT— 510(k) K131468

Substantially Equivalent

Green Dentech Co, Ltd.

FDA 510(k) clearance K131468 for DENRACLE DENTAL ABUTMENT, Substantially Equivalent on 2014-05-06. Applicant: Green Dentech Co, Ltd..

Clearance details

Applicant: Green Dentech Co, Ltd.
Product code: Code NHA
Advisory panel: Dental
Date received: 2013-05-21
Decision date: 2014-05-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tainan City, TW

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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, 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.