FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Vonflex S
K Number: K152615
·
Decision Nov 3, 2016
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
20
Review Days
416
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Basic Information
- Device Name
- Vonflex S
- K Number
- K152615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vericom Co., Ltd.
- Date Received
- September 14, 2015
- Decision Date
- November 3, 2016
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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| K170950 | Well-Root ST | Dec 20, 2017 | Substantially Equivalent |
| K163346 | MAZIC Duro | Mar 17, 2017 | Substantially Equivalent |
| K160377 | V-varnish Premium | Dec 2, 2016 | Substantially Equivalent |
| K152518 | Vonflex S Putty | Nov 30, 2015 | Substantially Equivalent |
| K140966 | VONFLEX S BITE | Aug 15, 2014 | Substantially Equivalent |
| K103164 | VONFLEX HEAVY, VINFLEX LIGHT | Nov 10, 2010 | Substantially Equivalent |