FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEXIM Implant; Samwon General Abutments
K Number: K243731
·
Decision Jul 9, 2025
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
1
Review Days
217
Basic Information
- Device Name
- HEXIM Implant; Samwon General Abutments
- K Number
- K243731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- P&A USA
- Date Received
- December 4, 2024
- Decision Date
- July 9, 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 |
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