Command Enamel-Dent Dental Adhesive

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

510(k) Number

K843025 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Handpiece, Lift, Endo

  Class I

  FDA 510(k) K780213 Active Cleared 17 Feb 1978

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  FDA 510(k) K843026 Active Cleared 27 Sep 1984

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  FDA 510(k) K872147 Active Cleared 26 Aug 1987

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  FDA 510(k) K843072 Active Cleared 7 Sep 1984

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  FDA 510(k) K780712 Active Cleared 17 May 1978

See all devices from Kerr Corporation (Danbury) →

• What is the Command Enamel-Dent Dental Adhesive used for?

  Command Enamel-Dent Dental Adhesive is classified as an Agent, Tooth Bonding, Resin and is designed for use in dental procedures to bond materials to tooth enamel. It is intended for dental specialty use.

• How is the Command Enamel-Dent Dental Adhesive supplied?

  The device is supplied by Kerr Corporation (Danbury). The specific packaging, sizes, or models available are not detailed in the provided information.

• What is the regulatory status of the Command Enamel-Dent Dental Adhesive?

  The Command Enamel-Dent Dental Adhesive received FDA 510(k) clearance with number K843025 on October 25, 1984. It is classified as Class II under regulation 872.3200 and is considered substantially equivalent to predicate devices.

• Is the Command Enamel-Dent Dental Adhesive single-use or reusable?

  The provided information does not specify whether the Command Enamel-Dent Dental Adhesive is designed for single-use or multiple uses. This detail would typically be found in the product's instructions for use.