510(k) K141611
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2014
- Date Received
- June 16, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- Device Class
- Class II
- Regulation Number
- 872.3661
- Review Panel
- DE
- Submission Type
An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.