FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NNC GOLD ABUTMENT FOR BRIDGES
K Number: K113606
·
Decision Jan 27, 2012
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
41
Review Days
52
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Basic Information
- Device Name
- NNC GOLD ABUTMENT FOR BRIDGES
- K Number
- K113606
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Straumann USA
- Date Received
- December 6, 2011
- Decision Date
- January 27, 2012
- 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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| K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM | Oct 3, 2011 | Substantially Equivalent |
| K111724 | STRAUMANN TIBRUSH | Sep 12, 2011 | Substantially Equivalent |