Apapro Desensitizer
FDA 510(k) clearance K220419 · decided 2022-02-16
Clearance details
- K-number
- K220419
- Device name
- Apapro Desensitizer
- Applicant
- Sangi Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-02-14
- Decision date
- 2022-02-16
- Days to decision
- 2 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tokyo, JP
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.