CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE— 510(k) K122427

Substantially Equivalent

Carestream Dental, LLC

FDA 510(k) clearance K122427 for CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE, Substantially Equivalent on 2012-09-12. Applicant: Carestream Dental, LLC.

Clearance details

Applicant: Carestream Dental, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-08-09
Decision date: 2012-09-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.