High-speed Turbine Handpieces for Single Use
FDA 510(k) clearance K172543 · decided 2018-07-11
Clearance details
- K-number
- K172543
- Device name
- High-speed Turbine Handpieces for Single Use
- Applicant
- Beijing Dongbo Dental Handpiece Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-23
- Decision date
- 2018-07-11
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.