FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Hi-Bond Universal
K Number: K230465
·
Decision May 22, 2023
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- Hi-Bond Universal
- K Number
- K230465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mediclus Co., Ltd.
- Date Received
- February 21, 2023
- Decision Date
- May 22, 2023
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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Other Clearances by Mediclus Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260485 | Any-Etch | May 14, 2026 | Substantially Equivalent |
| K260819 | Any-Com Seal | May 1, 2026 | Substantially Equivalent |
| K253797 | One-Stop | Feb 27, 2026 | Substantially Equivalent |
| K253167 | Any-Paste | Jan 12, 2026 | Substantially Equivalent |
| K252465 | Any-Core | Dec 5, 2025 | Substantially Equivalent |
| K251884 | One-Fil Putty Injectable | Aug 22, 2025 | Substantially Equivalent |
| K251283 | Once-Fil Flow | Jun 6, 2025 | Substantially Equivalent |
| 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 |