FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
DESS Dental Implants
K Number: K212538
·
Decision Dec 14, 2021
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
23
Review Days
124
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Basic Information
- Device Name
- DESS Dental Implants
- K Number
- K212538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terrats Medical SL
- Date Received
- August 12, 2021
- Decision Date
- December 14, 2021
- 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 Terrats Medical SL
| K Number | Device Name | ||
|---|---|---|---|
| K260564 | DESS Dental Smart Solutions | Jun 9, 2026 | Substantially Equivalent |
| 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 |