FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
CERACELL DENTAL
K Number: K103709
·
Decision Mar 10, 2011
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
10
Review Days
80
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Basic Information
- Device Name
- CERACELL DENTAL
- K Number
- K103709
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Curasan AG
- Date Received
- December 20, 2010
- Decision Date
- March 10, 2011
- 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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|---|---|---|---|
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| K111105 | CURASAN OSSEOLIVE DENTAL | Dec 20, 2012 | Substantially Equivalent |
| K102872 | OSBONE DENTAL | Jan 12, 2011 | Substantially Equivalent |
| K100841 | BONEOPTIMIZER | Aug 19, 2010 | Substantially Equivalent |
| K063106 | REVOIS IMPLANT SYSTEM | Jun 11, 2007 | Substantially Equivalent |
| K040216 | CERASORB M ORTHO | Mar 26, 2004 | Substantially Equivalent |
| K031651 | MODIFICATION TO CERASORB ORTHO | Aug 13, 2003 | Substantially Equivalent |
| K014156 | CERASORB ORTHO | Mar 18, 2002 | Substantially Equivalent |