Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
FDA 510(k) clearance K240337 · decided 2024-11-13
Clearance details
- K-number
- K240337
- Device name
- Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
- Applicant
- Guangdong Jinme Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-05
- Decision date
- 2024-11-13
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Foshan, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.