FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
NobelProcera Zirconia Implant Bridge
K Number: K202452
·
Decision Dec 3, 2020
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
92
Review Days
98
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Basic Information
- Device Name
- NobelProcera Zirconia Implant Bridge
- K Number
- K202452
- 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
- August 27, 2020
- Decision Date
- December 3, 2020
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Nobel Biocare AB
| K Number | Device Name | ||
|---|---|---|---|
| K252197 | Nobel Biocare S Series Implants | Feb 18, 2026 | Substantially Equivalent |
| K243834 | NobelZygoma TiUltra Implant system | Aug 25, 2025 | Substantially Equivalent |
| K240346 | NobelProcera Zirconia Implant Bridge | Jan 3, 2025 | Substantially Equivalent |
| 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 |
| K203156 | DTX Studio Clinic | Nov 20, 2020 | Substantially Equivalent |
| K202344 | TiUltra Implants and Xeal Abutments | Nov 16, 2020 | Substantially Equivalent |