← Back to catalogue

MaxCure 9 Curing Light

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223414

by Guilin Refine Medical Instrument Co., Ltd.

Identifiers

510(k) Number
K223414 FDA 510(k)
FDA Product Code
EBZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6070 FDA 510(k)
Regulation Number
872.6070 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MaxCure 9 Curing Light is a dental ultraviolet activator designed for polymerizing composite resins and other light-cured materials in restorative procedures. Classified as a Class II device under FDA regulations, it emits controlled ultraviolet light to initiate and complete the curing process of dental restorations, ensuring proper hardening of materials in clinical settings.

Supplied as a reusable device, the MaxCure 9 is intended for use in dental offices and clinics. It operates within regulatory frameworks including FDA 510(k) clearance and MDR compliance, with a traditional review pathway. The device is not single-use and requires proper maintenance, storage, and adherence to manufacturer guidelines to ensure safety and efficacy. No specific MRI safety information is provided, and its use is limited to dental applications as defined by its classification.

Frequently asked questions

What is the MaxCure 9 Curing Light primarily used for in dental procedures?

The MaxCure 9 Curing Light is designed specifically for polymerizing composite resins and other light-cured materials during dental restorative procedures. It emits controlled ultraviolet light to initiate and complete the curing process, ensuring proper hardening of materials in clinical settings like dental offices and clinics.

Is the MaxCure 9 a single-use device, or can it be reused in a clinical setting?

The MaxCure 9 is a reusable device, not intended for single-use. It requires proper maintenance, storage, and adherence to manufacturer guidelines to ensure safety and continued efficacy in dental applications.

What regulatory pathways has the MaxCure 9 followed for approval, and what does that mean for its use?

The MaxCure 9 has obtained FDA 510(k) clearance and complies with the Medical Device Regulation (MDR). It was classified as substantially equivalent under the FDA’s traditional review pathway, meaning it meets the same performance criteria as a legally marketed device. This ensures its use is limited to dental applications as defined by its classification, with no specific MRI safety information provided.

How should the MaxCure 9 be stored to maintain its functionality and safety?

While the device data does not specify storage conditions in detail, as a reusable Class II medical device, the MaxCure 9 should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture. Adherence to the manufacturer’s guidelines for maintenance and storage is critical to ensure proper performance and longevity.

What types of dental materials can the MaxCure 9 effectively cure?

The MaxCure 9 is designed for polymerizing composite resins and other light-cured materials commonly used in dental restorations. Its ultraviolet light output is tailored to initiate and complete the curing process for these materials, ensuring proper hardening during procedures like fillings, crowns, or bonding.

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

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Guilin Refine Medical Instrument Co., Ltd.

Sources (2)

  • FDA 510(k) K223414 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026