FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Premilled Titanium Block System
K Number: K203344
·
Decision Aug 25, 2021
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
15
Review Days
285
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Basic Information
- Device Name
- Premilled Titanium Block System
- K Number
- K203344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innobiosurg Co., Ltd.
- Date Received
- November 13, 2020
- Decision Date
- August 25, 2021
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 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 |
| K220079 | Magicore Narrow System | Dec 14, 2022 | Substantially Equivalent |
| K212517 | Magicore System | Oct 15, 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 |