510(k) clearance
DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece
- 510(k) number
- K262144
- Applicant
- SETAGAYA SEIKI Co., Ltd.
- Decision date
- Sep 23, 2026
- Date received
- Jun 25, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EFB
- Device type
- Handpiece, Air-Powered, Dental
- Device class
- Class I
- Regulation
- 21 CFR 872.4200
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Yonezawa-City, JP