FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMA-BSM; BETA-BSM; EQUIVABONE
K Number: K102812
·
Decision Dec 3, 2010
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
5
Review Days
66
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Basic Information
- Device Name
- GAMMA-BSM; BETA-BSM; EQUIVABONE
- K Number
- K102812
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Etex Corporation
- Date Received
- September 28, 2010
- Decision Date
- December 3, 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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Other Clearances by Etex Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) | Dec 18, 2024 | Substantially Equivalent |
| K182107 | CarriGen PF | Aug 31, 2018 | Substantially Equivalent |
| K132868 | CARRICELL | Feb 20, 2015 | Substantially Equivalent |
| K141245 | ETEX MIXING AND DELIVERY SYSTEM | Jul 9, 2014 | Substantially Equivalent |