FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
SIC PRO
K Number: K040757
·
Decision Apr 13, 2005
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
5
Review Days
384
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Basic Information
- Device Name
- SIC PRO
- K Number
- K040757
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sic Invent AG
- Date Received
- March 25, 2004
- Decision Date
- April 13, 2005
- 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 Sic Invent AG
| K Number | Device Name | ||
|---|---|---|---|
| K252904 | SIC Abutments including CAD/CAM Solutions | Jun 3, 2026 | Substantially Equivalent |
| K210489 | SICtapered & SICvantage tapered | Mar 17, 2022 | Substantially Equivalent |
| K173207 | SIC invent Dental Implant Systems | Apr 5, 2018 | Substantially Equivalent |
| K061500 | SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS | Aug 8, 2006 | Substantially Equivalent |