FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Geo Abutment
K Number: K242978
·
Decision Jun 16, 2025
Classifications
1
FEI Numbers
390
Registration Numbers
390
Same Product Code
672
Applicant Total
1
Review Days
263
Basic Information
- Device Name
- Geo Abutment
- K Number
- K242978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GeoMedi Co., Ltd.
- Date Received
- September 26, 2024
- Decision Date
- June 16, 2025
- 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 |
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