FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
CCM Abutment System
K Number: K173120
·
Decision Mar 16, 2018
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
15
Review Days
168
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CCM Abutment System
- K Number
- K173120
- 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
- September 29, 2017
- Decision Date
- March 16, 2018
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.
Neodent Scannable Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
SIC Abutments including CAD/CAM Solutions
FDA 510(k)
FDA Class 2
·Dental
Elos Accurate® Denture Fixation System
FDA 510(k)
FDA Class 2
·Dental
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
FDA 510(k)
FDA Class 2
·Dental
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 |
| 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 |