FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
OSTEON II
K Number: K112716
·
Decision Jan 17, 2012
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
18
Review Days
120
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Basic Information
- Device Name
- OSTEON II
- K Number
- K112716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genoss Co., Ltd.
- Date Received
- September 19, 2011
- Decision Date
- January 17, 2012
- Product Code
- LYC
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
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