FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-GRAFT
K Number: K033110
·
Decision Dec 10, 2003
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
1
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- C-GRAFT
- K Number
- K033110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Clinician'S Preference, LLC
- Date Received
- September 30, 2003
- Decision Date
- December 10, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYC), ordered by most recent decision date.
Bonalive Maxillofacial
FDA 510(k)
FDA Class 2
·Dental
BONTREE PLUS
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft M
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft B
FDA 510(k)
FDA Class 2
·Dental
Synthetic Bone Graft Particulate
FDA 510(k)
FDA Class 2
·Dental
CMFlexTM
FDA 510(k)
FDA Class 2
·Dental