DTX Studio Clinic 3.0— 510(k) K221921
Substantially EquivalentNobel Biocare AB
FDA 510(k) clearance K221921 for DTX Studio Clinic 3.0, Substantially Equivalent on 2023-03-28. Applicant: Nobel Biocare AB. Device class: 2.
Clearance details
- Applicant
- Nobel Biocare AB
- Product code
- Code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 411 17 Goteborg, SE
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