FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Straumann Variobase for CEREC
K Number: K151324
·
Decision Sep 11, 2015
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
24
Review Days
116
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
- Straumann Variobase for CEREC
- K Number
- K151324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Straumann USA, LLC
- Date Received
- May 18, 2015
- Decision Date
- September 11, 2015
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.
Neodent Scannable Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
SIC Abutments including CAD/CAM Solutions
FDA 510(k)
FDA Class 2
·Dental
Elos Accurate® Denture Fixation System
FDA 510(k)
FDA Class 2
·Dental
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Straumann USA, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | Nov 11, 2024 | Substantially Equivalent |
| K203753 | Straumann Surgical Cassettes | Jul 29, 2021 | Substantially Equivalent |
| K202942 | Straumann 4 mm Short Implants | Feb 8, 2021 | Substantially Equivalent |
| K192401 | Straumann Screw-Retained Abutments | Apr 6, 2020 | Substantially Equivalent |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | Jun 17, 2019 | Substantially Equivalent |
| K171784 | Straumann Dental Implant System | Jan 19, 2018 | Substantially Equivalent |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment | Mar 8, 2017 | Substantially Equivalent |
| K151590 | Straumann RN Gold Abutment for Bridge | Mar 4, 2016 | Substantially Equivalent |
| K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | Sep 16, 2015 | Substantially Equivalent |
| K151247 | NC Straumann Screw Retained Abutments | Aug 10, 2015 | Substantially Equivalent |