510(k) K261748
K261748 is an FDA 510(k) premarket notification submitted by Hefei Meyer Optoelectronic Technology, Inc. for the device "Dental Cone-beam Computed Tomography (mDX-15P Series)". The FDA issued a decision of Substantially Equivalent on July 23, 2026. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2026
- Date Received
- May 28, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- X-Ray, Tomography, Computed, Dental
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.