FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIO STEADY EXTERNAL IMPLANT SYSTEM
K Number: K100100
·
Decision Nov 10, 2010
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
4
Review Days
302
Basic Information
- Device Name
- DIO STEADY EXTERNAL IMPLANT SYSTEM
- K Number
- K100100
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DIO CORPORATION
- Date Received
- January 12, 2010
- Decision Date
- November 10, 2010
- 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 CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K161987 | UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure | Feb 21, 2017 | Substantially Equivalent |
| K122519 | DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM | May 21, 2013 | Substantially Equivalent |
| K112746 | DIOSLIMON IMPLANT SYSTEM | Oct 21, 2011 | Substantially Equivalent |