Corporate Dental Imaging (CDI) Application— 510(k) K151371

Substantially Equivalent

U.S. Army Dental Command (Dencom)

FDA 510(k) clearance K151371 for Corporate Dental Imaging (CDI) Application, Substantially Equivalent on 2015-08-19. Applicant: U.S. Army Dental Command (Dencom).

Clearance details

Applicant
U.S. Army Dental Command (Dencom)
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Sam Houston, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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.