FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYBONE DENTAL
K Number: K092194
·
Decision Jun 16, 2010
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
4
Review Days
330
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Basic Information
- Device Name
- POLYBONE DENTAL
- K Number
- K092194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kyung Won Medical Co., Ltd.
- Date Received
- July 21, 2009
- Decision Date
- June 16, 2010
- 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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