Deldent Ultrasonic Inserts

510(k) Number

K011179 ↗

FDA product code

ELC

FDA applicant

Deldent , Ltd.

Device class

Class II

Regulation

21 CFR Part 872.4850

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

• Ultrasonic Scaler Insert DF100/30K R

  Class II

  FDA 510(k) K011179 Active Cleared 5 Jun 2001 GUDID on market

• Jetpolisher 2000 Midwest 1.1

  Class II

  FDA 510(k) K014249 Active Cleared 19 Feb 2002 GUDID on market

• Ultrasonic Scaler Insert DP100/25K L

  Class II

  FDA 510(k) K011179 Active Cleared 5 Jun 2001 GUDID on market

• Ultrasonic Scaler Insert DF1000/30K

  Class II

  FDA 510(k) K011179 Active Cleared 5 Jun 2001 GUDID on market

See all devices from Deldent Ltd. →