FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
NobelClinician, DTX Studio implant
K Number: K163122
·
Decision Jan 31, 2017
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
92
Review Days
84
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Basic Information
- Device Name
- NobelClinician, DTX Studio implant
- K Number
- K163122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobel Biocare AB
- Date Received
- November 8, 2016
- Decision Date
- January 31, 2017
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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|---|---|---|---|
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| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | Jan 24, 2024 | Substantially Equivalent |
| K231898 | DTX Studio Clinic (4.0) | Dec 8, 2023 | Substantially Equivalent |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | Apr 28, 2023 | Substantially Equivalent |
| K221921 | DTX Studio Clinic 3.0 | Mar 28, 2023 | Substantially Equivalent |
| K213562 | DTX Studio Clinic 3.0 | Mar 25, 2022 | Substantially Equivalent |
| K202452 | NobelProcera Zirconia Implant Bridge | Dec 3, 2020 | Substantially Equivalent |
| K203156 | DTX Studio Clinic | Nov 20, 2020 | Substantially Equivalent |