510(k) K141611
K141611 is an FDA 510(k) premarket notification submitted by Ormco Corp. for the device "LYTHOS DIGITAL IMPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 5, 2014. The device falls under product code NOF (System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations), a Class II device regulated under 21 CFR 872.3661. Ormco Corp. has at least 10 other 510(k) clearances on record.
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.