Cooral System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by BrainCool AB
Identifiers
- 510(k) Number
- DEN210027 FDA 510(k)
- FDA Product Code
- QUA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5590 FDA 510(k)
- Regulation Number
- 872.5590 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Cooral System is an Intraoral Cooling Device, classified as a Class II medical device under FDA regulations (21 CFR 872.5590). It is designed for intraoral application to provide localized cooling during dental procedures, helping to manage patient comfort and thermal sensitivity.
This device is supplied as a reusable system and is intended for use in dental settings. It is not sterile at time of shipment and must be cleaned and maintained according to manufacturer instructions. The Cooral System is authorized under the FDA 510(k) pathway and complies with the Medical Device Directive (MDD). No MRI safety information is specified, and sizes or additional regulatory details beyond the above are not provided in the data.
Frequently asked questions
Is the Cooral System intended for single-use or can it be reused in a clinical setting?
The Cooral System is designed as a reusable intraoral cooling device. It is not sterile at the time of shipment and must be cleaned and maintained according to the manufacturer’s instructions before each use. This ensures proper hygiene and functionality for repeated applications in dental procedures.
How is the Cooral System authorized for use in the United States and Europe?
The Cooral System is authorized through the FDA’s 510(k) pathway, meaning it has been cleared as substantially equivalent to a legally marketed predicate device under 21 CFR 872.5590. It also complies with the Medical Device Directive (MDD) in Europe, meeting regulatory requirements for Class II devices in dental applications.
What type of maintenance or cleaning is required for the Cooral System before use?
Since the Cooral System is reusable and not sterile upon shipment, it must be thoroughly cleaned and maintained following the manufacturer’s guidelines to ensure proper functionality and infection control. Specific cleaning protocols are provided to prepare the device for intraoral application during dental procedures.
Can the Cooral System be used with patients who have dental implants or other oral prosthetics?
The Cooral System is designed for intraoral cooling during dental procedures, but its compatibility with dental implants or oral prosthetics depends on the specific design and placement of those devices. Clinicians should verify that the cooling application area is accessible and safe for use with the patient’s existing oral structures before application.
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 (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN210027 | Class II | Active |
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Manufacturer
- Manufacturer
- BrainCool AB
Sources (2)
- FDA 510(k) DEN210027 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026