FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Magicore Narrow System
K Number: K220079
·
Decision Dec 14, 2022
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
15
Review Days
338
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Basic Information
- Device Name
- Magicore Narrow System
- K Number
- K220079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innobiosurg Co., Ltd.
- Date Received
- January 10, 2022
- Decision Date
- December 14, 2022
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Innobiosurg Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220517 | IBS System | Dec 20, 2022 | Substantially Equivalent |
| K212517 | Magicore System | Oct 15, 2021 | Substantially Equivalent |
| K203344 | Premilled Titanium Block System | Aug 25, 2021 | Substantially Equivalent |
| K202418 | Magic UCLA Abutment System | Dec 3, 2020 | Substantially Equivalent |
| K202479 | IBS Implant System | Sep 23, 2020 | Substantially Equivalent |
| K201981 | Magicore System | Aug 27, 2020 | Substantially Equivalent |
| K201621 | Magicore II System | Jul 15, 2020 | Substantially Equivalent |
| K200753 | IBS Implant System II | Jun 9, 2020 | Substantially Equivalent |
| K192197 | Magicore II System | Apr 28, 2020 | Substantially Equivalent |
| K173120 | CCM Abutment System | Mar 16, 2018 | Substantially Equivalent |