CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES— 510(k) K133069

Substantially Equivalent

Codent Technical Industry Co., Ltd.

FDA 510(k) clearance K133069 for CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES, Substantially Equivalent on 2014-10-24. Applicant: Codent Technical Industry Co., Ltd..

Clearance details

Applicant: Codent Technical Industry Co., Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2013-09-30
Decision date: 2014-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung City, TW

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.