Identifiers
- 510(k) Number
- K922249 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Flexi-Flow Cement Natural is a dental cement intended for use in dental applications. It is classified as a Class II medical device under the regulation number 872.3275.
The device is supplied by Essential Dental Systems, Inc. and has received FDA 510(k) clearance. The device is not indicated for any specific clinical use.
Frequently asked questions
What is Flexi-Flow Cement Natural?
Flexi-Flow Cement Natural is a dental cement intended for use in dental applications. It is classified as a Class II medical device under regulation number 872.3275.
Who manufactures Flexi-Flow Cement Natural?
The device is supplied by Essential Dental Systems, Inc., which is based in Great Neck, New York.
What is the regulatory status of Flexi-Flow Cement Natural?
The device has received FDA 510(k) clearance. It is not indicated for any specific clinical use.
What is the device classification?
Flexi-Flow Cement Natural is classified as a Class II medical device under the regulation number 872.3275.
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: Flexi-Flow Natural Composite Cement with Fluoride from Essential Dental ..., Flexi-Flow Auto E Titanium-Reinforced Post Cement | Essential Dental ..., PDF Flexi-Flow Auto® E, Flexi-Flow - ESSENTIAL DENTAL SYSTEMS - PDF Catalogs - MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K922249 | Class II | Active |
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Manufacturer
- Manufacturer
- Essential Dental Systems, Inc.
Sources (1)
- FDA 510(k) K922249 24 fields · synced Sep 25, 2026