Diagnodent Perio Tip (Accessory)

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

510(k) Number

K042394 ↗

FDA Product Code

NBL

Device Class

Class II

Regulation

21 CFR Part 872.1745

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• In Exam Intraoral Dental X-Ray System

  Class II

  FDA 510(k) K050019 Active Cleared 31 Jan 2005

• Diagnodent

  Class II

  FDA 510(k) K051909 Active Cleared 21 Oct 2005

• Rondoflex Plus 360

  Class II

  FDA 510(k) K042872 Active Cleared 23 Nov 2004

• Kavo Everest C-Temp

  Class II

  FDA 510(k) K063624 Active Cleared 8 Feb 2007

• Kavo Everest Titanblank

  Class II

  FDA 510(k) K024214 Active Cleared 12 Mar 2003

• Prophypearls

  Class I

  FDA 510(k) K031868 Active Cleared 9 Jul 2003

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• What is the DIAGNODENT PERIO TIP (ACCESSORY) used for?

  It is a laser fluorescence caries detection device accessory designed for use with the DIAGNOdent system to induce fluorescence in subgingival dental calculus for the detection of caries using a 655 nm diode laser.

• How is the DIAGNODENT PERIO TIP (ACCESSORY) supplied and is it sterile?

  It is supplied as a non-sterile, reusable accessory probe intended for dental clinical settings, meaning it is not provided sterile and is designed for multiple uses after proper cleaning and reprocessing.

• What regulatory clearance does the DIAGNODENT PERIO TIP (ACCESSORY) have?

  The device has received FDA 510(k) clearance under K042394 and is classified as a Class II medical device under regulation number 872.1745 with product code NBL.