DTX Studio design
FDA 510(k) clearance K181932 · decided 2019-03-01
Clearance details
- K-number
- K181932
- Device name
- DTX Studio design
- Applicant
- Nobel Biocare AB
- Decision
- Substantially Equivalent
- Date received
- 2018-07-19
- Decision date
- 2019-03-01
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- PNP
- 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.