Identifiers
- 510(k) Number
- K955759 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 Litex 680 is an ultraviolet activator used for polymerization in dental applications. This device functions as a light curing unit designed to facilitate the hardening of dental materials.
This device is a gun-type unit featuring a 75-watt, 12V tungsten halogen lamp and a 9mm standard probe. It includes an internally-mounted fan for continuous operation and an automatic timer that allows for preselection of cure times between 10 and 60 seconds. The device is authorized via FDA 510(k) clearance.
Frequently asked questions
What is the primary function of the Litex 680?
The Litex 680 is an ultraviolet activator designed for polymerization in dental applications. It functions as a light curing unit to facilitate the hardening of dental materials.
What are the technical specifications of the curing unit?
The device is a gun-type unit equipped with a 75-watt, 12V tungsten halogen lamp and a 9mm standard probe. It includes an internally-mounted fan to support continuous operation.
How are the curing times controlled?
The unit features an automatic timer that allows the clinician to preselect cure times ranging from 10 to 60 seconds, providing control over the polymerization process.
What is the regulatory status of this device?
The Litex 680 is authorized via FDA 510(k) clearance, which indicates it has been reviewed and found to be substantially equivalent to other legally marketed devices.
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: DENTAMERICA, Litex 680a (Dentamerica) | Dental Product | Pearson Dental, Dentamerica Litex 680A Curing Light, 680A - Independent Dental, Inc., Litex 680A Light Curing Unit, Dentamerica, Prestige Dental Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955759 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentamerica
Sources (1)
- FDA 510(k) K955759 24 fields · synced Sep 27, 2026