CHROMASCAN TM
Device Facts
| Record ID | K770667 |
|---|---|
| Device Name | CHROMASCAN TM |
| Applicant | Sterndent Corp. |
| Product Code | KZN · Dental |
| Decision Date | Apr 20, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3661 |
| Device Class | Class 2 |
Regulatory Classification
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.
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).
