FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERMAMESH-D HYDROXYLAPATITE MATRIX
K Number: K960361
·
Decision Apr 15, 1996
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
16
Review Days
81
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Basic Information
- Device Name
- PERMAMESH-D HYDROXYLAPATITE MATRIX
- K Number
- K960361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceramed Corp.
- Date Received
- January 25, 1996
- Decision Date
- April 15, 1996
- 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 Ceramed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K962838 | PERMARIDGE SYRINGE | Aug 20, 1996 | Substantially Equivalent |
| K962786 | OSTEOGRAF STAINLESS STEEL SYRING | Aug 1, 1996 | Substantially Equivalent |
| K960348 | OSTEOGRAF/N-300 HYDROXYLAPATITE | Apr 22, 1996 | Substantially Equivalent |
| K960353 | OSTEOGRAF/LD-300 HYDROXYLAPATITE | Apr 18, 1996 | Substantially Equivalent |
| K960368 | OSTEOGRAFT/N-700 HYDROXYLAPTITE | Apr 18, 1996 | Substantially Equivalent |
| K960362 | PERMAMESH HYDROXYLAPATITE MATRIX | Mar 20, 1996 | Substantially Equivalent |
| K960354 | PERMAMESH-D HYDROXYLAPATITE MATRIX | Mar 20, 1996 | Substantially Equivalent |
| K960349 | PERMARIDGE HYDROXYLAPATITE MATRIX | Mar 13, 1996 | Substantially Equivalent |
| K954631 | OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE | Jan 2, 1996 | Substantially Equivalent |
| K942946 | OSTEOGRAF/D-100 HYDROXYLAPATITE | Oct 5, 1994 | Substantially Equivalent |