System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
The optical impression system for CAD/CAM of dental restorations is a dental device that records the topographical characteristics of teeth, impressions, or stone models using analog or digital methods to facilitate computer-aided design and manufacturing of dental prosthetics. The system typically consists of a camera or scanner and a computer with specialized software. It is classified as FDA Class 2 under regulation 872.3661 in the Dental specialty, and while Class 2 normally requires 510(k) notification, submission type 4 indicates this product code is 510(k) exempt. Product code NOF is not eligible for third-party review.
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Basic Information
- Product Code
- NOF
- Device Class
- FDA class 2
- Regulation Number
- 872.3661
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM | Dec 05, 2014 | Substantially Equivalent | Ormco Corp. |
| K122065 | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | Feb 08, 2013 | Substantially Equivalent | Ormco Corp. |
| K122467 | 3M TRUE DEFINITION SCANNER | Nov 20, 2012 | Substantially Equivalent | 3M Company |
| K081961 | 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER | Sep 05, 2008 | Substantially Equivalent | Brontes Technologies |
| K073199 | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER | Dec 21, 2007 | Substantially Equivalent | Brontes Technologies |
FEI Numbers
This FDA classification entry is associated with 151 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 151 registration numbers. Click on an entry to view related FDA registrations.