Elipar Freelight

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K011154 ↗

FDA Product Code

EBZ

Device Class

Class II

Regulation

21 CFR Part 872.6070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Hytac

  Class II

  FDA 510(k) K992909 Active Cleared 24 Nov 1999

• Impregum Penta M Monosoft

  Class II

  FDA 510(k) K994192 Active Cleared 28 Jan 2000

• Pentamix 2

  Class I

  FDA 510(k) K991913 Active Cleared 26 Jul 1999

• Vitron M

  Class II

  FDA 510(k) K990763 Active Cleared 25 May 1999

• Vestogum

  Class II

  FDA 510(k) K991221 Active Cleared 20 May 1999

• Ketac Cem U

  Class II

  FDA 510(k) K002793 Active Cleared 26 Sep 2000

See all devices from Espe Dental AG →

• What is the Elipar Freelight used for?

  The Elipar Freelight is a cordless polymerization unit designed for intraoral use. It serves as a light source for polymerizing dental materials within the mouth, providing dentists with a portable and convenient solution for dental procedures.

• How is the Elipar Freelight supplied?

  The device consists of a charger and a cordless handpiece powered by a rechargeable battery. This configuration allows for cordless operation while ensuring the device can be easily recharged between uses.

• What is the regulatory status of the Elipar Freelight?

  The Elipar Freelight has received FDA 510(k) clearance with the product code EBZ. It was determined to be substantially equivalent to other legally marketed devices and is intended for dental use.

• Is the Elipar Freelight a single-use device?

  The device is not specified as single-use in the provided information. It is a cordless handpiece with a rechargeable battery, suggesting it is designed for multiple uses with proper charging and maintenance.