FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Paltop Dental Implant System
K Number: K243983
·
Decision Sep 29, 2025
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
7
Review Days
280
Basic Information
- Device Name
- Paltop Dental Implant System
- K Number
- K243983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paltop Advanced Dental Solutions, Ltd.
- Date Received
- December 23, 2024
- Decision Date
- September 29, 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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Other Clearances by Paltop Advanced Dental Solutions, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232740 | Paltop Short Implants | May 22, 2024 | Substantially Equivalent |
| K220200 | Paltop Conical Implant System | May 25, 2022 | Substantially Equivalent |
| K210117 | Paltop Narrow Implant | Nov 30, 2021 | Substantially Equivalent |
| K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | Aug 27, 2013 | Substantially Equivalent |
| K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | Aug 22, 2013 | Substantially Equivalent |
| K112795 | PALTOP DENTAL IMPLANT SYSTEM | Apr 20, 2012 | Substantially Equivalent |