FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
MBA Biotech Implant System
K Number: K243002
·
Decision Jun 6, 2025
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
1
Review Days
253
Basic Information
- Device Name
- MBA Biotech Implant System
- K Number
- K243002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MBA Biotech Co., Ltd.
- Date Received
- September 26, 2024
- Decision Date
- June 6, 2025
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.
HEXIM Implant; Samwon General Abutments
FDA 510(k)
FDA Class 2
·Dental
URIS Long Implant & Abutments
FDA 510(k)
FDA Class 2
·Dental
T3 Pro Implants ZimVie Packaging System
FDA 510(k)
FDA Class 2
·Dental
Bioline Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
CeraRoot TL Implant System (TL)
FDA 510(k)
FDA Class 2
·Dental
OsseOne Dental Implant System
FDA 510(k)
FDA Class 2
·Dental