K122065 is an FDA 510(k) clearance for the DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE. This device is classified as a System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations (Class II - Special Controls, product code NOF).
Submitted by Ormco Corp. (Orange, US). The FDA issued a Cleared decision on February 8, 2013, 210 days after receiving the submission on July 13, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3661. 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..
| 510(k) Number | K122065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2012 |
| Decision Date | February 08, 2013 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NOF — System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3661 |
| Definition | 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. |