Sapphire Plasma Arc Dental Curing Light
510(k) K081287
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081287 | Date21 Nov 2008 | 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- Withdrawn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, 20 Sep 2026
The Sapphire Plasma Arc Dental Curing Light is a dental device classified as an ultraviolet activator for polymerization. It employs plasma arc technology to rapidly cure dental composites, resins, and other light-activated materials used in restorative procedures. The device delivers high-intensity light to ensure efficient curing in minimal time, supporting precision in dental applications such as fillings, crowns, and bonding agents.
This device is intended for use in dental offices and clinics, where it is operated by trained dental professionals. Supplied as a reusable instrument, it requires proper handling and maintenance to ensure optimal performance and safety. The Sapphire Plasma Arc Dental Curing Light is FDA-cleared under the 510(k) pathway, with a classification of Class II, and adheres to regulatory standards for dental devices. It is not intended for single-use and must be cleaned and sterilized according to manufacturer guidelines.
Other devices from Den-Mat Holdings, LLC
Questions
AI-generated answers, 20 Sep 2026
What types of dental materials can the Sapphire Plasma Arc Dental Curing Light cure, and why is plasma arc technology preferred in these applications?
The Sapphire Plasma Arc Dental Curing Light is designed to rapidly cure dental composites, resins, and other light-activated materials commonly used in restorative procedures such as fillings, crowns, and bonding agents. Plasma arc technology is preferred because it delivers high-intensity light, ensuring efficient and thorough curing in minimal time. This precision reduces potential errors in dental work and supports faster treatment times, which is particularly beneficial for clinicians managing multiple procedures.
Is the Sapphire Plasma Arc Dental Curing Light intended for single-use, or is it meant to be reused in a clinical setting? What maintenance is required?
The Sapphire Plasma Arc Dental Curing Light is explicitly designed as a reusable instrument for use in dental offices and clinics. Since it is not single-use, it must be cleaned and sterilized according to the manufacturer’s guidelines to ensure optimal performance, safety, and longevity. Proper maintenance is critical to prevent contamination and preserve its functionality for repeated use.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in dental practices?
The Sapphire Plasma Arc Dental Curing Light was cleared through the FDA’s 510(k) pathway, specifically under an abbreviated clearance (decision code: SESE) and classified as Class II. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness. Clinicians can rely on this clearance as evidence of regulatory scrutiny before use in dental practices.
How does the Sapphire Plasma Arc Dental Curing Light differ from traditional curing lights in terms of curing speed and efficiency?
The Sapphire Plasma Arc Dental Curing Light uses plasma arc technology to deliver high-intensity light, which significantly accelerates the curing process compared to traditional curing lights. This rapid curing capability ensures dental composites and resins achieve full polymerization in less time, improving workflow efficiency and reducing patient chair time while maintaining precision in restorative procedures.