FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
DESS Dental Smart Solutions
K Number: K250639
·
Decision May 22, 2025
Classifications
1
FEI Numbers
390
Registration Numbers
390
Same Product Code
672
Applicant Total
18
Review Days
80
Basic Information
- Device Name
- DESS Dental Smart Solutions
- K Number
- K250639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terrats Medical SL
- Date Received
- March 3, 2025
- Decision Date
- May 22, 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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Other Clearances by Terrats Medical SL
| K Number | Device Name | ||
|---|---|---|---|
| K243212 | DESS Dental Smart Solutions | Feb 14, 2025 | Substantially Equivalent |
| K242340 | DESS Dental Smart Solutions | Nov 5, 2024 | Substantially Equivalent |
| K240982 | DESS Dental Smart Solutions | Aug 26, 2024 | Substantially Equivalent |
| K240208 | DESS Dental Smart Solutions | Apr 24, 2024 | Substantially Equivalent |
| K233316 | DESS Dental Smart Solutions | Jan 5, 2024 | Substantially Equivalent |
| K231434 | DESS Dental Smart Solutions | Aug 14, 2023 | Substantially Equivalent |
| K230143 | DESS Dental Smart Solutions | Apr 13, 2023 | Substantially Equivalent |
| K221301 | DESS Dental Smart Solutions | Mar 9, 2023 | Substantially Equivalent |
| K222288 | DESS Dental Smart Solutions | Oct 27, 2022 | Substantially Equivalent |
| K222269 | DESS Dental Smart Solutions | Oct 26, 2022 | Substantially Equivalent |