DTX Studio design— 510(k) K181932
Substantially EquivalentNobel Biocare AB
FDA 510(k) clearance K181932 for DTX Studio design, Substantially Equivalent on 2019-03-01. Applicant: Nobel Biocare AB. Device class: 2.
Clearance details
- Applicant
- Nobel Biocare AB
- Product code
- Code PNP
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goteborg, SE
Recent devices under product code PNP
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