NobelDesign, DTX Studio Design
FDA 510(k) clearance K171466 · decided 2017-11-29
Clearance details
- K-number
- K171466
- Device name
- NobelDesign, DTX Studio Design
- Applicant
- Nobel Biocare AB
- Decision
- Substantially Equivalent
- Date received
- 2017-05-18
- Decision date
- 2017-11-29
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Goteborg, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.