FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
VioSeal
K Number: K242702
·
Decision Nov 7, 2024
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
17
Review Days
59
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Basic Information
- Device Name
- VioSeal
- K Number
- K242702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spident Co., Ltd.
- Date Received
- September 9, 2024
- Decision Date
- November 7, 2024
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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|---|---|---|---|
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| K241445 | K-Bond Universal | Jul 22, 2024 | Substantially Equivalent |
| K231523 | EsCom250 | Jul 24, 2023 | Substantially Equivalent |
| K214076 | EsCem | Dec 19, 2022 | Substantially Equivalent |
| K214071 | Hexa-Temp | Mar 10, 2022 | Substantially Equivalent |
| K161774 | i-Sil | Sep 30, 2016 | Substantially Equivalent |
| K134022 | BASE IT | Jun 11, 2014 | Substantially Equivalent |
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