510(k) K253864
K253864 is an FDA 510(k) premarket notification submitted by Dental Imaging Technologies Corporation for the device "NOMAD Pro 3". The FDA issued a decision of Substantially Equivalent on March 20, 2026. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Dental Imaging Technologies Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2026
- Date Received
- December 3, 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