Elevate Oral Care, LLC

Elevate Oral Care, LLC specializes in dental care devices, primarily focusing on tooth-desensitizing and protective coatings. Their portfolio includes fluoride varnishes (like FluoriMax in various flavors), professional-grade desensitizing agents, artificial saliva sprays and gels (e.g., Allday), single-use tongue scrapers, and glass ionomer dental cements (e.g., Advantage Arrest). These products target oral health concerns such as sensitivity, dry mouth, and cavity prevention.

Elevate Oral Care, LLC is based in the United States, which means its devices are primarily regulated under FDA guidelines. The company’s products are subject to FDA 510(k) clearance requirements and UDI (Unique Device Identification) mandates. Some of its devices are also listed in the EU’s eudamed database, indicating compliance with EU regulatory pathways, though this does not imply EU approval—only that the data is recorded for transparency.

Elevate Oral Care’s devices appear in the FDA’s 510(k) and UDI registries, which track cleared products and their identification codes for traceability. Additionally, some entries are listed in the EU’s eudamed database, a central repository for medical device information in the European Economic Area. These registries help healthcare providers, regulators, and distributors verify device compliance and availability, ensuring proper use and reducing risks.

Elevate Oral Care’s devices fall into different risk-based classifications depending on their purpose and potential harm. Most of their products, such as fluoride varnishes and artificial saliva sprays, are classified as Class I (low risk) or Class II (moderate risk), requiring specific regulatory controls like 510(k) clearances. Some specialized products, like certain dental cements, may also be classified as Unclassified (U), meaning they are exempt from traditional classification but still subject to FDA oversight.

Devices listed in eudamed are recorded there due to their potential for distribution or use in the EU market, even if they are primarily cleared in the US. The inclusion in eudamed does not mean the devices are approved for sale in Europe—it simply reflects that the manufacturer has provided data about them to the EU’s regulatory transparency system. This helps EU authorities track devices that may enter the market, ensuring compliance with EU medical device regulations.