DeviceClearance

GC AADVA BO AC ABUTMENTS— 510(k) K103234

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K103234 for GC AADVA BO AC ABUTMENTS, Substantially Equivalent on 2011-06-30. Applicant: GC America, Inc.. Device class: 2.

Clearance details

Applicant
GC America, Inc.
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
Lake Bluff, IL, US
Download summary PDFView on FDA.gov ↗

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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.