FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
IPD Dental Implant Abutments
K Number: K242819
·
Decision Dec 19, 2024
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
6
Review Days
92
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Basic Information
- Device Name
- IPD Dental Implant Abutments
- K Number
- K242819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implant Protesis Dental 2004, S.L.
- Date Received
- September 18, 2024
- Decision Date
- December 19, 2024
- 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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Other Clearances by Implant Protesis Dental 2004, S.L.
| K Number | Device Name | ||
|---|---|---|---|
| K253253 | IPDmilled Blanks | Jan 22, 2026 | Substantially Equivalent |
| K251471 | IPD Dental Implant Abutments | Aug 20, 2025 | Substantially Equivalent |
| K240570 | IPD Dental Implant Abutments | Jun 7, 2024 | Substantially Equivalent |
| K231413 | IPD Dental Implant Abutments | Oct 10, 2023 | Substantially Equivalent |
| K222215 | IPD Dental Implant Abutments | Oct 21, 2022 | Substantially Equivalent |