Cool Cure
by Samm, Inc.
510(k) K030811
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030811 | Date10 Jun 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EBZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6070
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Cool Cure is an ultraviolet activator designed for polymerizing dental restorative materials. It functions as a curing light, emitting controlled illumination to harden composite resins, adhesives, and other light-cured dental materials in the oral cavity.
This device is intended for use in dental offices and clinics, supplied as a reusable instrument. It has received FDA 510(k) clearance under the classification name 'Activator, Ultraviolet, For Polymerization' (Regulation 872.6070) and is classified as a Class II medical device. No specific sterility or MRI safety information is provided in the data.
Questions
AI-generated answers, 19 Sep 2026
What types of dental materials can the Cool Cure activate or cure, and how does it differ from other curing lights?
The Cool Cure is specifically designed to polymerize dental restorative materials that require ultraviolet (UV) activation, such as composite resins and adhesives. Unlike some curing lights that use visible light, this device emits controlled ultraviolet illumination to harden these materials in the oral cavity. This makes it suitable for applications where UV-sensitive materials are used, ensuring precise curing for dental restorations.
Is the Cool Cure a single-use device or can it be reused in a clinical setting?
The Cool Cure is supplied as a reusable instrument, meaning it is intended for repeated use in dental offices and clinics. Since it is not described as disposable or single-use, proper cleaning and maintenance procedures should be followed to ensure its continued effectiveness and safety between uses.
What regulatory pathway was followed for the FDA clearance of the Cool Cure, and what does this mean for its use in dental practices?
The Cool Cure received FDA clearance through a 510(k) Traditional pathway under the classification 'Activator, Ultraviolet, For Polymerization' (Regulation 872.6070). This means the manufacturer demonstrated that it is substantially equivalent to a legally marketed device already on the market, ensuring it meets FDA safety and performance standards. Clinicians can rely on this clearance as evidence that the device has undergone review by the FDA for its intended use in polymerizing dental materials.
Are there any specific storage requirements for the Cool Cure, and how should it be handled to maintain its functionality?
The provided data does not specify any particular storage requirements for the Cool Cure, such as temperature or environmental conditions. However, as a reusable medical device, it should be stored in a clean, dry place away from direct sunlight or extreme temperatures to prevent damage. Proper handling, including regular cleaning and maintenance, will help ensure its longevity and reliable performance in curing dental materials.