FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
K Number: K090083
·
Decision Mar 23, 2009
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
7
Review Days
70
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Basic Information
- Device Name
- CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
- K Number
- K090083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unicare Biomedical, Inc.
- Date Received
- January 12, 2009
- Decision Date
- March 23, 2009
- 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 Unicare Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Nov 19, 2015 | Substantially Equivalent |
| K092567 | MODIFICATION TO UNIGRAFT | Nov 25, 2009 | Substantially Equivalent |
| K080532 | BENACEL, MODELS C-001, C-002 AND C-005 | Nov 12, 2008 | Substantially Equivalent |
| K021511 | CYTOFLEX MESH | Aug 6, 2002 | Substantially Equivalent |
| K020720 | OSSIFORM | May 7, 2002 | Substantially Equivalent |
| K012144 | CYTOFLEX | Oct 1, 2001 | Substantially Equivalent |