FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
DESS Dental Smart Solutions
K Number: K260564
·
Decision Jun 9, 2026
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
23
Review Days
110
Basic Information
- Device Name
- DESS Dental Smart Solutions
- K Number
- K260564
- 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
- February 19, 2026
- Decision Date
- June 9, 2026
- 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 | ||
|---|---|---|---|
| K253804 | DESS Dental Smart Solutions | Apr 16, 2026 | Substantially Equivalent |
| K251547 | DESS Dental Smart Solutions | Oct 31, 2025 | Substantially Equivalent |
| K252384 | DESS® Dental Smart Solutions | Oct 23, 2025 | Substantially Equivalent |
| K251280 | DESS® Dental Implants | Jul 23, 2025 | Substantially Equivalent |
| K250639 | DESS Dental Smart Solutions | May 22, 2025 | Substantially Equivalent |
| 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 |