Recognized standard
Technical Report No. 146-2018
FDA recognition 4-270 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-270 |
|---|---|
| Designation | Technical Report No. 146-2018 |
| Title | CAD/CAM Abutments in Dentistry |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | CAD/CAM abutments have an anatomically correct emergence profile and restoration substructure specific to the patient (i.e. patient specific). This technical report provides references for test methods that can be used for assessing reliability, accuracy and reproducibility of patient specific… |
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: