FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOGEN (HA RESORB)
K Number: K923310
·
Decision May 31, 1995
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
5
Review Days
1058
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Basic Information
- Device Name
- OSTEOGEN (HA RESORB)
- K Number
- K923310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Impladent
- Date Received
- July 7, 1992
- Decision Date
- May 31, 1995
- 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 Impladent
| K Number | Device Name | ||
|---|---|---|---|
| K881662 | EXPANDED CLAIMES TO OSTEOGEN(R) | Sep 1, 1988 | Substantially Equivalent for Some Indications |
| K843398 | OSTEOGEN | Dec 27, 1984 | Substantially Equivalent |
| K812321 | HYDROXI-FLEX IMPLANT | Oct 29, 1981 | Substantially Equivalent |
| K792663 | FLEXI-CUP IMPLANT | Jan 9, 1980 | Substantially Equivalent |