FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
OsOpia Synthetic Bone Void Filler
K Number: K201546
·
Decision Oct 2, 2020
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
1
Review Days
115
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Basic Information
- Device Name
- OsOpia Synthetic Bone Void Filler
- K Number
- K201546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Revisios BV
- Date Received
- June 9, 2020
- Decision Date
- October 2, 2020
- 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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