FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SM INTERNAL./EXTERNAL IMPLANT SYSTEM
K Number: K070569
·
Decision Nov 8, 2007
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
8
Review Days
253
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Basic Information
- Device Name
- SM INTERNAL./EXTERNAL IMPLANT SYSTEM
- K Number
- K070569
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dio Department Dsi, Inc.
- Date Received
- February 28, 2007
- Decision Date
- November 8, 2007
- 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 Dio Department Dsi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080129 | SECURE IMPLANT SYSTEM (2.5/3.0MM) | May 30, 2008 | Substantially Equivalent |
| K073070 | DIO BIOTITE-H IMPLANT SYSTEM | May 16, 2008 | Substantially Equivalent |
| K080128 | SM-EXTRA WIDE (RBM) IMPLANT SYSTEM | May 14, 2008 | Substantially Equivalent |
| K070570 | DIO IMPLANT SYSTEM | Apr 15, 2008 | Substantially Equivalent |
| K080126 | DIO PROTEM IMPLANT SYSTEM | Apr 11, 2008 | Substantially Equivalent |
| K070568 | DIO PROTEM IMPLANT SYSTEM | May 25, 2007 | Substantially Equivalent |
| K061797 | SM IMPLANT SYSTEMS | Sep 1, 2006 | Substantially Equivalent |