510(k) K252110
K252110 is an FDA 510(k) premarket notification submitted by Guangzhou Ajax Medical Equipment Co., Ltd. for the device "Dental X-RAY Unit (AJX200)". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Guangzhou Ajax Medical Equipment Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2026
- Date Received
- July 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type