FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Once-Fil Flow
K Number: K251283
·
Decision Jun 6, 2025
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
13
Review Days
42
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Basic Information
- Device Name
- Once-Fil Flow
- K Number
- K251283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mediclus Co., Ltd.
- Date Received
- April 25, 2025
- Decision Date
- June 6, 2025
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Mediclus Co., Ltd.
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|---|---|---|---|
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| K252465 | Any-Core | Dec 5, 2025 | Substantially Equivalent |
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| K250823 | Any-Com Flow | Apr 14, 2025 | Substantially Equivalent |
| K243353 | One-Fil Putty | Mar 14, 2025 | Substantially Equivalent |
| K242713 | Any-Com Bulk | Feb 7, 2025 | Substantially Equivalent |
| K241147 | Any-Com | Sep 26, 2024 | Substantially Equivalent |