FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOGRAF 2040 OSTEOGRAF 4060
K Number: K852199
·
Decision Oct 7, 1985
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
24
Review Days
140
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Basic Information
- Device Name
- OSTEOGRAF 2040 OSTEOGRAF 4060
- K Number
- K852199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Osteotech, Inc.
- Date Received
- May 20, 1985
- Decision Date
- October 7, 1985
- 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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| K080511 | PLEXUR-P | Apr 21, 2008 | Substantially Equivalent |
| K073405 | PLEXUR M | Mar 3, 2008 | Substantially Equivalent |
| K061982 | PLEXUR P | Feb 7, 2007 | Substantially Equivalent |
| K051188 | GRAFTON DBM | Jan 3, 2006 | Substantially Equivalent |
| K051781 | GRAFTCAGE TLX | Dec 16, 2005 | Substantially Equivalent |
| K051195 | GRAFTON DBM | Dec 16, 2005 | Substantially Equivalent |
| K043209 | VIAGRAF DBM PASTE | Dec 5, 2005 | Substantially Equivalent |
| K053080 | GRAFTCAGE ACX | Dec 1, 2005 | Substantially Equivalent |