Avex CX2— 510(k) K152779
Substantially EquivalentOpal Orthodontics by Ultradent Products
FDA 510(k) clearance K152779 for Avex CX2, Substantially Equivalent on 2015-11-25. Applicant: Opal Orthodontics by Ultradent Products. Device class: 2.
Clearance details
- Applicant
- Opal Orthodontics by Ultradent Products
- Product code
- Code NJM
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Jordan, UT, US
Recent devices under product code NJM
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