FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Internal Hex Implant System
K Number: K190837
·
Decision Jan 22, 2020
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
4
Review Days
296
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Basic Information
- Device Name
- Internal Hex Implant System
- K Number
- K190837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ebi, Inc.
- Date Received
- April 1, 2019
- Decision Date
- January 22, 2020
- 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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