FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSSEOSPEED ANGLED ABUTMENT EV
K Number: K121810
·
Decision Jan 23, 2013
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
10
Review Days
217
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Basic Information
- Device Name
- OSSEOSPEED ANGLED ABUTMENT EV
- K Number
- K121810
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astra Tech AB
- Date Received
- June 20, 2012
- Decision Date
- January 23, 2013
- 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 Astra Tech AB
| K Number | Device Name | ||
|---|---|---|---|
| K120414 | OSSEOSPEED PLUS | Jul 31, 2012 | Substantially Equivalent |
| K113424 | LOFRIC SINGLE USE URINARY CATHETER | Apr 17, 2012 | Substantially Equivalent |
| K111287 | ASTRA TECH IMPLANT SYSTEM | Sep 26, 2011 | Substantially Equivalent |
| K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Jun 21, 2011 | Substantially Equivalent |
| K101732 | ASTRA TECH IMPLANT SYSTEM | Feb 23, 2011 | Substantially Equivalent |
| K091239 | ASTRA TECH IMPLANT SYSTEM | Sep 22, 2009 | Substantially Equivalent |
| K080156 | OSSEOSPEED TM PROFILE SYSTEM | Sep 17, 2008 | Substantially Equivalent |
| K080396 | OSSEOSPEED NARROW | Apr 30, 2008 | Substantially Equivalent |
| K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Oct 1, 2007 | Substantially Equivalent |