Lee Composite Inlay System

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

510(k) Number

K873123 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Precise(R) Beta Quartz Glass-Ceramic Insert

  Class II

  FDA 510(k) K912256 Active Cleared 24 Jul 1991

• Lee Endofill, Root Canal Filling Resin

  Class II

  FDA 510(k) K810923 Active Cleared 21 Apr 1981

• Ultraviolet Rad-Emitting Lamp

  Class II

  FDA 510(k) K771077 Active Cleared 24 Jun 1977

• Restobond 3/Dentin-Enamel Bonding Agent

  Class II

  FDA 510(k) K894315 Active Cleared 31 Oct 1989

• Cleanse N Bond I

  Class II

  FDA 510(k) K844133 Active Cleared 4 Jan 1985

• Restodent Vl

  Class II

  FDA 510(k) K843363 Active Cleared 25 Oct 1984

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• What is the Lee Composite Inlay System used for?

  The Lee Composite Inlay System is a dental restoration system designed for covering prepared tooth cavities with composite materials. It includes proximal inlays of different sizes and occlusal inlays, along with a curable restorative resin to secure the proximal inlay in a blocking position during dental procedures.

• How is the Lee Composite Inlay System supplied?

  The system is supplied as a complete dental restoration kit that includes various sized proximal inlays, occlusal inlays, and a curable restorative resin. It is intended for professional dental use in restoring prepared tooth cavities with composite materials.

• What regulatory authorization does the Lee Composite Inlay System have?

  The Lee Composite Inlay System is authorized under FDA 510K clearance with the K number K873123. It has been determined to be substantially equivalent to other legally marketed devices and is classified under product code EBF with a dental advisory committee review.

• Is the Lee Composite Inlay System single-use or reusable?

  The device data does not specify whether the Lee Composite Inlay System is single-use or reusable. However, as it includes a curable restorative resin and is designed for dental restoration procedures, it is typically used in clinical settings where infection control protocols determine appropriate usage based on the specific components.