FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cytoflex Tefguard Ti-Enforced Membrane
K Number: K151344
·
Decision Nov 19, 2015
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
7
Review Days
184
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Basic Information
- Device Name
- Cytoflex Tefguard Ti-Enforced Membrane
- K Number
- K151344
- 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
- May 19, 2015
- Decision Date
- November 19, 2015
- Product Code
- NPK
- 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 |
|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPK), ordered by most recent decision date.
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Bio-MEM Ti Reinforced Membrane
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Cytoplast Titanium-Reinforced PTFE Membranes
FDA 510(k)
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RPM Reinforced PTFE Mesh
FDA 510(k)
FDA Class 2
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Other Clearances by Unicare Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K092567 | MODIFICATION TO UNIGRAFT | Nov 25, 2009 | Substantially Equivalent |
| K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | Mar 23, 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 |