FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
K Number: K142890
·
Decision Jan 9, 2015
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
24
Review Days
98
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Basic Information
- Device Name
- Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
- K Number
- K142890
- 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
- October 3, 2014
- Decision Date
- January 9, 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 |
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Other Clearances by Straumann USA, LLC
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K151324 | Straumann Variobase for CEREC | Sep 11, 2015 | Substantially Equivalent |