FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXI-CUP IMPLANT
K Number: K792663
·
Decision Jan 9, 1980
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
5
Review Days
14
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Basic Information
- Device Name
- FLEXI-CUP IMPLANT
- K Number
- K792663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Impladent
- Date Received
- December 26, 1979
- Decision Date
- January 9, 1980
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Impladent
| K Number | Device Name | ||
|---|---|---|---|
| K923310 | OSTEOGEN (HA RESORB) | May 31, 1995 | Substantially Equivalent |
| 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 |