Hygientist; Cycloson I & II; Retrofit

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

510(k) Number

K812909 ↗

FDA Product Code

ELC

Models / Variants

Hygientist

Cycloson I & Ii

Retrofit

Device Class

Class II

Regulation

21 CFR Part 872.4850

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 Ussta

  Unclassified

  FDA 510(k) K980930 Active Cleared 22 Sep 1998

• Ultrasonic Lithotriptor 300A

  Class II

  FDA 510(k) K842024 Active Cleared 11 Dec 1984

• Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model Ls-2000

  Class II

  FDA 510(k) K993046 Active Cleared 22 Nov 1999

• Fibra-Sonics Phaco III or Iiip Fragmentation System

  Class II

  FDA 510(k) K984143 Active Cleared 16 Feb 1999

• Phaco Fragmentor Gt-1

  Class II

  FDA 510(k) K834453 Active Cleared 16 Mar 1984

• Lewicky Anterior Chamber Mainten. Sys.

  Class II

  FDA 510(k) K802381 Active Cleared 17 Dec 1980

See all devices from Fibra Sonics, Inc. →

• What is the Hygienist Cycloson I II Retrofit used for?

  The Hygienist Cycloson I II Retrofit is an ultrasonic scaler device designed specifically for cleaning and scaling procedures in dental settings. It helps dental professionals perform efficient and precise scaling treatments.

• How is the Hygienist Cycloson I II Retrofit supplied?

  The device is supplied by Fibra Sonics, Inc. It is classified as a Class II medical device with product code ELC, and comes with the necessary components for dental scaling procedures as provided by the manufacturer.

• What is the regulatory status of the Hygienist Cycloson I II Retrofit?

  The device received FDA 510(k) clearance on December 14, 1981, with regulation number 872.4850. It is classified as substantially equivalent to predicate devices in the dental ultrasonic scaler category.

• Is the Hygienist Cycloson I II Retrofit reusable or single-use?

  The device information does not specify whether it is designed for single-use or multiple reuse. This detail would be provided in the product's instructions for use, which should be consulted for proper handling and sterilization protocols.