FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LL Implant System
K Number: K242379
·
Decision Nov 7, 2024
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
7
Review Days
87
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Basic Information
- Device Name
- LL Implant System
- K Number
- K242379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ossvis Co., Ltd.
- Date Received
- August 12, 2024
- Decision Date
- November 7, 2024
- 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 Ossvis Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242703 | LW Pre-milled Abutment | Dec 5, 2024 | Substantially Equivalent |
| K233808 | LW Narrow Implant System | Jul 31, 2024 | Substantially Equivalent |
| K233167 | LW Implant System Abutment | Mar 25, 2024 | Substantially Equivalent |
| K231235 | LW UCLA Abutment | Sep 15, 2023 | Substantially Equivalent |
| K231079 | LW Retraction Cap | Sep 14, 2023 | Substantially Equivalent |
| K223924 | LW Implant System | Aug 8, 2023 | Substantially Equivalent |