FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SuperLine
K Number: K213599
·
Decision Feb 23, 2022
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
22
Review Days
100
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Basic Information
- Device Name
- SuperLine
- K Number
- K213599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentium Co., Ltd.
- Date Received
- November 15, 2021
- Decision Date
- February 23, 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 Dentium Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K193341 | iCTmotor (WL-1) | Sep 4, 2020 | Substantially Equivalent |
| K192436 | Healing Abutments and Cover Screws | Jan 23, 2020 | Substantially Equivalent |
| K191634 | Scan Abutments and Comfort Caps | Nov 4, 2019 | Substantially Equivalent |
| K172640 | Dentium Implantium & SuperLine Prosthetics | May 14, 2018 | Substantially Equivalent |
| K171622 | Dentium Ti-Base | Jan 11, 2018 | Substantially Equivalent |
| K171126 | Implantium II | Sep 7, 2017 | Substantially Equivalent |
| K170384 | Dentium NR Line CAD/CAM Abutments | Aug 17, 2017 | Substantially Equivalent |
| K160965 | SuperLine | Jan 13, 2017 | Substantially Equivalent |
| K161713 | Dentium CAD/CAM Abutments | Dec 16, 2016 | Substantially Equivalent |
| K160828 | Dentium Implantium & SuperLine Prosthetics | Sep 15, 2016 | Substantially Equivalent |