Identifiers
- 510(k) Number
- K053088 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Our SLACTIVE IMPLANTS device is a revolutionary dental implant system designed to provide a lifelike and durable solution for patients seeking to restore their natural teeth. With its unique feature of adjustable load distribution, this implant system offers unparalleled comfort and stability, allowing patients to enjoy optimal oral health and confidence in their smile.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053088 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (1)
- FDA 510(k) K053088 24 fields · synced Jul 19, 2026