MDK HANDPIECES— 510(k) K141886
Substantially EquivalentModern Korea Co., Ltd.
FDA 510(k) clearance K141886 for MDK HANDPIECES, Substantially Equivalent on 2015-05-13. Applicant: Modern Korea Co., Ltd..
Clearance details
- Applicant
- Modern Korea Co., Ltd.
- Product code
- Code EFB
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fullerton, CA, US
Adverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
Source: openFDA MAUDE database, through . 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.