Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)— 510(k) K240337
Substantially EquivalentGuangdong Jinme Medical Technology Co., Ltd.
FDA 510(k) clearance K240337 for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L), Substantially Equivalent on 2024-11-13. Applicant: Guangdong Jinme Medical Technology Co., Ltd..
Clearance details
- Applicant
- Guangdong Jinme Medical Technology Co., Ltd.
- Product code
- Code EFB
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
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.