GC AADVA ABUTMENT— 510(k) K072100

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K072100 for GC AADVA ABUTMENT, Substantially Equivalent on 2008-02-14. Applicant: GC America, Inc..

Clearance details

Applicant: GC America, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2007-07-31
Decision date: 2008-02-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lake Forest, IL, US

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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.