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Spring PowerLite 2000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992728

by Spring Health Products, Inc.

Identifiers

510(k) Number
K992728 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 Spring PowerLite 2000 is an Activator, Ultraviolet, For Polymerization device, classified under FDA product code EBZ. It is designed to initiate and accelerate the polymerization process in dental materials, ensuring proper curing of composites and other light-activated resins used in restorative dentistry.

This device is intended for use in dental settings and has received FDA 510(k) clearance under the Traditional pathway. It is classified as a Class II device under special controls and is supplied as a reusable instrument. No specific sterility or MRI safety information is provided in the regulatory data, but compliance with dental practice standards for infection control is implied. The device is authorized for use in the United States.

Frequently asked questions

What is the primary purpose of the Spring PowerLite 2000 in dental procedures?

The Spring PowerLite 2000 is designed specifically to initiate and accelerate the polymerization process in dental materials. It uses ultraviolet light to ensure proper curing of composites and other light-activated resins, which is essential for restorative dentistry procedures like fillings and crowns.

Is the Spring PowerLite 2000 a single-use or reusable device?

The Spring PowerLite 2000 is supplied as a reusable instrument. While no explicit sterility information is provided in the regulatory data, it is implied that it must comply with standard dental practice infection control protocols to ensure safe reuse in clinical settings.

What regulatory pathway was followed for FDA clearance of the Spring PowerLite 2000?

The Spring PowerLite 2000 received FDA clearance through the Traditional 510(k) pathway, classified as a Class II device under special controls. The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device.

Are there different models or sizes available for the Spring PowerLite 2000?

The provided data lists multiple registration numbers (e.g., 2523990, 3038718579, etc.), which may correspond to different configurations or variants of the device. However, specific details about distinct models, sizes, or their intended use are not explicitly described in the regulatory summary. For precise model variations, consulting the manufacturer’s documentation or support would be necessary.

How should the Spring PowerLite 2000 be stored to maintain its functionality?

While the regulatory data does not specify storage instructions, as a reusable ultraviolet polymerization device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Adherence to manufacturer guidelines for maintenance and care is recommended to ensure optimal performance and longevity.

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. Sources consulted: SPRING POWERLITE 2000 (K992728) — FDA 510(k) | Innolitics, K992728 FDA 510 (k) - SPRING POWERLITE 2000, PDF K992728 - Spring Powerlite 2000, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spring Health Products, Inc.

Sources (1)

  • FDA 510(k) K992728 24 fields · synced Sep 18, 2026