Swissmeda Dental Planning System
FDA 510(k)Class II (US FDA 510(k))
by Swissmeda AG
Identifiers
- 510(k) Number
- K112251 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Swissmeda Dental Planning System is a server-based online system designed for dental implant surgery planning. It reduces the effort required for the exchange of design data to a mouse click and provides an open framework application that integrates cloud-based planning with guide design to improve surgery times and patient outcomes.
The system is supplied as a software solution for use in clinical settings to support collaboration from planning to surgery. It is authorized under FDA 510(k) clearance (K112251) with product code LLZ and was determined to be substantially equivalent. The device is manufactured by Swissmeda AG in Zurich, Switzerland.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SMOP Swissmeda AG, Swissmeda - Carestream Dental, SMOP by Swissmeda | Carestream Dental, SMOP Swissmeda AG
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112251 | Class II | Active |
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Manufacturer
- Manufacturer
- Swissmeda AG
Sources (1)
- FDA 510(k) K112251 24 fields · synced Sep 22, 2026