Recognized standard
Standard No. 132-2015
FDA recognition 4-256 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-256 |
|---|---|
| Designation | Standard No. 132-2015 |
| Title | Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: