Mousse, Polyvinyl Siloxane Impression Material
FDA 510(k)Class II (US FDA 510(k))
by Parkell
Identifiers
- 510(k) Number
- K905032 FDA 510(k)
- FDA Product Code
- ELW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3660 FDA 510(k)
- Regulation Number
- 872.3660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mousse, Polyvinyl Siloxane Impression Material is a dental impression material used to create accurate impressions and bite registrations. It is designed to provide dental professionals with a versatile material for both traditional and digital workflows.
This material is supplied as a single-use product and is not MRI safe. It is manufactured by Parkell and has FDA 510K clearance with product code ELW. The device is classified as Class II and is regulated under number 872.3660.
Frequently asked questions
What is the Mousse Polyvinyl Siloxane Impression Material used for?
This dental impression material is designed to create accurate impressions and bite registrations, making it versatile for both traditional and digital dental workflows.
Is the Mousse Polyvinyl Siloxane Impression Material single-use or reusable?
The material is supplied as a single-use product, meaning it should be discarded after each patient use to ensure optimal results and maintain hygiene standards.
What is the regulatory status of this impression material?
The Mousse Polyvinyl Siloxane Impression Material has FDA 510K clearance with product code ELW and is classified as Class II, regulated under number 872.3660.
Is this material safe for MRI procedures?
No, this material is not MRI safe and should not be used in MRI environments as it may interfere with the imaging process.
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: Impression Materials - Parkell, Mousse, Polyvinyl Siloxane Impression Material, Blu-Mousse® Bite Registration - Parkell Inc., MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K905032 | Class II | Active |
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Manufacturer
- Manufacturer
- Parkell
Sources (1)
- FDA 510(k) K905032 24 fields · synced Sep 25, 2026