FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSSEOSPEED NARROW
K Number: K080396
·
Decision Apr 30, 2008
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
10
Review Days
77
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Basic Information
- Device Name
- OSSEOSPEED NARROW
- K Number
- K080396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astra Tech AB
- Date Received
- February 13, 2008
- Decision Date
- April 30, 2008
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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| K091239 | ASTRA TECH IMPLANT SYSTEM | Sep 22, 2009 | Substantially Equivalent |
| K080156 | OSSEOSPEED TM PROFILE SYSTEM | Sep 17, 2008 | Substantially Equivalent |
| K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Oct 1, 2007 | Substantially Equivalent |