SIMPLELINE II ABUTMENT SYSTEM— 510(k) K112045

Substantially Equivalent

Dentium Co., Ltd.

FDA 510(k) clearance K112045 for SIMPLELINE II ABUTMENT SYSTEM, Substantially Equivalent on 2012-01-26. Applicant: Dentium Co., Ltd..

Clearance details

Applicant: Dentium Co., Ltd.
Product code: Code NHA
Advisory panel: Dental
Date received: 2011-07-18
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Suwon-Si, Gyeonggi-Do, KR

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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, 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.