510(k) K081961
K081961 is an FDA 510(k) premarket notification submitted by Brontes Technologies for the device "3M UNITEK LAVA CHAIRSIDE ORAL SCANNER". The FDA issued a decision of Substantially Equivalent on September 5, 2008. 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. Brontes Technologies has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2008
- Date Received
- July 9, 2008
- 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.