K170104

Substantially Equivalent

COMPACT S, COMPACT S (LED)

Applicant: Dmetec.Co., Ltd.
Product code: ELC
Advisory panel: Dental
Date received: 2017-01-12
Decision date: 2017-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.