| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
051
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Date of Entry 01/14/2019
|
|
FR Recognition Number
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4-256
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| Standard | |
ANSI ADA Standard No. 132-2015
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
|
Scope/Abstract| 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. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| 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
|
|
Relevant FDA Guidance and/or Supportive Publications*
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.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
|
| Standards Development Organizations
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
