FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCS-B
K Number: K113246
·
Decision Jan 16, 2013
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
1
Review Days
441
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Basic Information
- Device Name
- OCS-B
- K Number
- K113246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nibec Company, Limited
- Date Received
- November 2, 2011
- Decision Date
- January 16, 2013
- Product Code
- NPM
- 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 |
|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | FDA class 2 | Dental |
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