FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
DTX Studio design
K Number: K181932
·
Decision Mar 1, 2019
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
7
Applicant Total
92
Review Days
225
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Basic Information
- Device Name
- DTX Studio design
- K Number
- K181932
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobel Biocare AB
- Date Received
- July 19, 2018
- Decision Date
- March 1, 2019
- Product Code
- PNP
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PNP | Dental Abutment Design Software For Dental Laboratory | FDA class 2 | Dental |
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