NOF · System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Dental · 21 CFR 872.3661 · Class 2
Overview
| Product Code | NOF |
|---|---|
| Device Name | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Regulation | 21 CFR 872.3661 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
An optical impression system for computer assisted design and manufacturing (CAD/CAM) 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-assisted 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.
Classification Rationale
Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).
Special Controls
*Classification.* Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM | Ormco Corp. | Dec 5, 2014 | SESE |
| K122065 | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | Ormco Corp. | Feb 8, 2013 | SESE |
| K122467 | 3M TRUE DEFINITION SCANNER | 3M Company | Nov 20, 2012 | SESE |
| K081961 | 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies | Sep 5, 2008 | SESE |
| K073199 | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies | Dec 21, 2007 | SESE |
Top Applicants
- Brontes Technologies — 2 clearances
- Ormco Corp. — 2 clearances
- 3M Company — 1 clearance
