510(k) K210820
K210820 is an FDA 510(k) premarket notification submitted by Alliage S/A Industrias Medico Odontológica for the device "EAGLE EDGE AXR90 and AXR120". The FDA issued a decision of Substantially Equivalent on Aug 10, 2021. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. Alliage S/A Industrias Medico Odontológica has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 10, 2021
- Date Received
- Mar 19, 2021
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- X-Ray, Tomography, Computed, Dental
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.