FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOPORE DENTAL IMPLANT ABUTMENTS
K Number: K952434
·
Decision Jul 19, 1995
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
6
Review Days
56
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Basic Information
- Device Name
- ENDOPORE DENTAL IMPLANT ABUTMENTS
- K Number
- K952434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innova Corp.
- Date Received
- May 24, 1995
- Decision Date
- July 19, 1995
- 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 Innova Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K040714 | HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT | Apr 9, 2004 | Substantially Equivalent |
| K984117 | INNOVA TELESCOPIC DISTRACTOR | Feb 10, 1999 | Substantially Equivalent |
| K971196 | ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM | May 8, 1997 | Substantially Equivalent |
| K926354 | ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM | Feb 13, 1995 | Substantially Equivalent |
| K915361 | THE BODY BUGGY | Dec 20, 1991 | Substantially Equivalent |