FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray
K Number: K203765
·
Decision Jul 20, 2021
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
8
Review Days
209
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray
- K Number
- K203765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zirkonzahn Srl
- Date Received
- December 23, 2020
- Decision Date
- July 20, 2021
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
CustoMED Viewer
FDA 510(k)
FDA Class 2
·Radiology
Helion Viewer Suite
FDA 510(k)
FDA Class 2
·Radiology
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
FDA 510(k)
FDA Class 2
·Radiology
SubtleHD-PET (1.x)
FDA 510(k)
FDA Class 2
·Radiology
HipGuide (V 1.0.0.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Zirkonzahn Srl
| K Number | Device Name | ||
|---|---|---|---|
| K232691 | Polibond | Sep 5, 2023 | Substantially Equivalent |
| K213722 | ICE Ceramics, ICE Stains, Fresco | Dec 14, 2022 | Substantially Equivalent |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Jul 8, 2020 | Substantially Equivalent |
| K190518 | Color Liquid, Vita Liquid | Nov 22, 2019 | Substantially Equivalent |
| K183304 | Prettau, ICE, Z-White zirconia blanks | Apr 4, 2019 | Substantially Equivalent |
| K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | Jun 18, 2018 | Substantially Equivalent |
| K132230 | ICE ZIRKON TRANSLUZENT | Nov 5, 2014 | Substantially Equivalent |