Pekalux/Gluma Light Cured Anterior Restorative Sys

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K872272 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Utility Wax Strips, Cinnamon

  Class I

  FDA 510(k) K880606 Active Cleared 24 Mar 1988

• Lumifor(Tm) Composite

  Class II

  FDA 510(k) K871165 Active Cleared 3 Apr 1987

• Gluma(Tm) Bonding System

  Class II

  FDA 510(k) K871164 Active Cleared 2 Jul 1987

• Shur Gel

  Class II

  FDA 510(k) K830083 Active Cleared 7 Feb 1983

• Ortho-Bite Wax Wafer

  Class I

  FDA 510(k) K863758 Active Cleared 7 Oct 1986

• Pekalux(Tm)

  Class II

  FDA 510(k) K872243 Active Cleared 7 Jul 1987

See all devices from Columbus Dental Mfg. Co. →

• What types of dental procedures is the Pekalux/Gluma Light Cured Anterior Restorative System specifically designed for?

  The Pekalux/Gluma Light Cured Anterior Restorative System is designed exclusively for direct restorative procedures on anterior (front) teeth. It uses light-curing technology to harden the composite material, making it suitable for filling cavities, repairing chips, or restoring tooth structure in the visible front teeth area.

• Is this system intended for reuse in a dental office, or is it meant to be used only once?

  The Pekalux/Gluma Light Cured Anterior Restorative System is single-use only, following standard sterility protocols for composite resins in dental offices. Each application requires a fresh kit, ensuring patient safety and compliance with dental best practices.

• Does this system come with multiple shade options for matching natural tooth color?

  Yes, the system includes a range of tooth shade options tailored for anterior restorations. These shades are designed to closely match the natural color of front teeth, allowing for more aesthetically pleasing and realistic restorations.

• How is the Pekalux/Gluma system supplied, and what components are included?

  The system is supplied as a complete kit containing all necessary components for anterior restorations, though no specific size variations are mentioned in the regulatory submission. It adheres to standard composite resin handling protocols, ensuring ease of use in dental offices.