KERATOR— 510(k) K132144

Substantially Equivalent

LK Consulting Group USA, Inc.

FDA 510(k) clearance K132144 for KERATOR, Substantially Equivalent on 2014-03-21. Applicant: LK Consulting Group USA, Inc..

Clearance details

Applicant: LK Consulting Group USA, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2013-07-11
Decision date: 2014-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.