| ANSI ADA Standard No. 132 - 2015 Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| Recognition Number | Dental/ENT |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 4-256 |
| Extent | Complete standard |
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| STG | Dental/ENT |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard describes test methods used to evaluate the repeatability, reproducibility and accuracy of dental devices for 3D metrology. The standard is applicable to dental chairside and dental laboratory CAD/CAM systems. The scope of this document is not intended to include unique systems with other specific applications of 3D metrology in the dental field such as 3D computed tomography, magnetic resonance imaging and stereophotogrammetry.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3661 | Scanner, Color | Class 2 | KZN |
| §872.3661 | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | NOF |
| 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, Issued April 22, 2003. |