510(k) clearance
Hand-held Dental X-ray System (HyperLight-M)
- 510(k) number
- K260795
- Applicant
- Changzhou Sifary Medical Technology Co., Ltd.
- Decision date
- Sep 14, 2026
- Date received
- Mar 11, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EHD
- Device type
- Unit, X-Ray, Extraoral With Timer
- Device class
- Class II
- Regulation
- 21 CFR 872.1800
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Changzhou, CN