FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
NEOSS ACCESS ABUTMENTS
K Number: K081851
·
Decision Mar 2, 2009
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
9
Review Days
245
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Basic Information
- Device Name
- NEOSS ACCESS ABUTMENTS
- K Number
- K081851
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neoss, Ltd.
- Date Received
- June 30, 2008
- Decision Date
- March 2, 2009
- 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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|---|---|---|---|
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| K113376 | NEOSS PROACTIVE TAPERED IMPLANT | Sep 5, 2012 | Substantially Equivalent |
| K090452 | NEOSS IMPLANT SYSTEM 03.25 | May 22, 2009 | Substantially Equivalent |
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| K071838 | NEOSS VARIOUS TITANIUM ABUTMENTS | Oct 19, 2007 | Substantially Equivalent |
| K043195 | NEO IMPLANT SYSTEM | Mar 7, 2005 | Substantially Equivalent |