FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIOUS DENTAL IMPLANTS WITH COVER SCREWS
K Number: K961861
·
Decision Aug 22, 1996
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
1
Review Days
100
Basic Information
- Device Name
- VARIOUS DENTAL IMPLANTS WITH COVER SCREWS
- K Number
- K961861
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- IMPLANT MANAGEMENT OF AMERICA
- Date Received
- May 14, 1996
- Decision Date
- August 22, 1996
- 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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