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Prelude Tongue Suspension System
FDA 510(k)Class II (US FDA 510(k))
510(k) K101060
Identifiers
- 510(k) Number
- K101060 FDA 510(k)
- FDA Product Code
- ORY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Prelude Tongue Suspension System is a dental device. It is classified as a tongue suspension system.
The device is supplied by Siesta Medical, Inc. and has a product code of ORY. It is a class 2 device with regulation number 872.5570. The device has been cleared with FDA 510K authorization.
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.
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 | K101060 | Class II | Active |
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Manufacturer
- Manufacturer
- Siesta Medical, Inc.
Sources (1)
- FDA 510(k) K101060 24 fields · synced Oct 6, 2026