FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPLANT Online Case Review and SIMPLANT Editor
K Number: K161118
·
Decision Jul 28, 2016
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
65
Review Days
99
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
- SIMPLANT Online Case Review and SIMPLANT Editor
- K Number
- K161118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Sirona
- Date Received
- April 20, 2016
- Decision Date
- July 28, 2016
- 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 Dentsply Sirona
| K Number | Device Name | ||
|---|---|---|---|
| K260785 | DS Core CBCT Anatomy | Apr 23, 2026 | Substantially Equivalent |
| K253959 | Primevision 3D | Feb 5, 2026 | Substantially Equivalent |
| K252343 | Atlantis® Abutments in Titanium | Dec 9, 2025 | Substantially Equivalent |
| K252248 | CEREC Tessera Abutment System | Nov 26, 2025 | Substantially Equivalent |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Nov 21, 2025 | Substantially Equivalent |
| K250295 | Dentsply Sirona Titanium Bases system | Apr 30, 2025 | Substantially Equivalent |
| K250081 | Atlantis® Abutments in Titanium | Apr 11, 2025 | Substantially Equivalent |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Oct 24, 2024 | Substantially Equivalent |
| K241557 | Cercon® yo ML | Aug 28, 2024 | Substantially Equivalent |
| K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System | May 7, 2024 | Substantially Equivalent |