FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
JDZygoma dental implants
K Number: K240143
·
Decision Oct 11, 2024
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
5
Review Days
267
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Basic Information
- Device Name
- JDZygoma dental implants
- K Number
- K240143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jdentalcare Srl
- Date Received
- January 18, 2024
- Decision Date
- October 11, 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 Jdentalcare Srl
| K Number | Device Name | ||
|---|---|---|---|
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Sep 25, 2025 | Substantially Equivalent |
| K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | Aug 16, 2024 | Substantially Equivalent |
| K182081 | JDentalCare Implant System JDIcon | Jun 26, 2020 | Substantially Equivalent |
| K143142 | JDENTALCARE Implant System | Nov 6, 2015 | Substantially Equivalent |