510(k) K052422
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2005
- Date Received
- September 2, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.1810
- Review Panel
- RA
- Submission Type