FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELL-PASTE
K Number: K090992
·
Decision Apr 21, 2009
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
20
Review Days
14
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Basic Information
- Device Name
- WELL-PASTE
- K Number
- K090992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vericom Co., Ltd.
- Date Received
- April 7, 2009
- Decision Date
- April 21, 2009
- Product Code
- KIF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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|---|---|---|---|
| K260805 | Dual Core | May 11, 2026 | Substantially Equivalent |
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| K203672 | MAZIC Claro CAD and MAZIC Claro Press | Jul 1, 2021 | Substantially Equivalent |
| K193260 | U-Cem Premium & MAZIC Cem | Aug 21, 2020 | Substantially Equivalent |
| 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 |
| K152615 | Vonflex S | Nov 3, 2016 | Substantially Equivalent |
| K152518 | Vonflex S Putty | Nov 30, 2015 | Substantially Equivalent |
| K140966 | VONFLEX S BITE | Aug 15, 2014 | Substantially Equivalent |