Coradent

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

510(k) Number

K901260 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• D-Sign VI (R&D Project DW266#9)

  Class II

  FDA 510(k) K990235 Active Cleared 1 Mar 1999

• Biouniversal Pdf

  Class II

  FDA 510(k) K011022 Active Cleared 2 May 2001

• Fermit N Plus

  Class II

  FDA 510(k) K003377 Active Cleared 4 Dec 2000

• Tetric Flow

  Class II

  FDA 510(k) K993783 Active Cleared 13 Dec 1999

• Sr-Isosit Spectra Link System

  Class II

  FDA 510(k) K910069 Active Cleared 2 Mar 1992

• Basic Calcium Hydroxide Liner

  Class II

  FDA 510(k) K896529 Active Cleared 16 Jan 1990

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• What is the Coradent used for in dental procedures?

  The Coradent is a rubber cup attachment designed specifically for dental prophylaxis, polishing, and finishing of teeth. It is intended to be used with a dental handpiece or air polishing systems to achieve smooth, clean tooth surfaces during routine dental care or restorative procedures.

• Is the Coradent available in single-use or reusable versions?

  The Coradent is supplied as either a single-use or reusable accessory, depending on the clinical preference and infection control protocols. Single-use versions ensure sterility for each patient, while reusable versions require proper cleaning, sterilization, and maintenance to maintain compatibility with dental handpieces and prevent cross-contamination.

• How does sterility factor into the use of the Coradent?

  Sterility is critical when using the Coradent, particularly in clinical settings. Single-use versions eliminate the need for sterilization between patients, ensuring a sterile field. For reusable versions, adherence to strict sterilization protocols (e.g., autoclaving or chemical sterilization) is mandatory to prevent bacterial or viral transmission and maintain device integrity.

• What regulatory pathway does the Coradent follow in the U.S.?

  The Coradent is regulated under the FDA’s 510(k) clearance pathway, classified under product code EBF (Dental Prophylaxis, Polishing, and Finishing Instruments). It was granted clearance in 1990 (K901260) and is substantiated as substantially equivalent to a predicate device, adhering to 21 CFR 872.3690. This classification ensures it meets safety and effectiveness standards for dental use.

• Can the Coradent be used with any dental handpiece?

  The Coradent is designed to be compatible with standard dental handpieces and air polishing systems, but compatibility may vary depending on the specific brand and model. Clinicians should verify fitment and functionality with their existing equipment to ensure optimal performance and prevent damage to either the handpiece or the attachment.