DELDENT ULTRASONIC INSERTS


Device Classification Name

scaler, ultrasonic

510(k) Number K011179
Device Name DELDENT ULTRASONIC INSERTS
Original Applicant
DELDENT LTD.
19 keren kayemet st.
petach tikvah, 

IL

49372

Original Contact alan edel
Regulation Number 872.4850
Classification Product Code
ELC  
Date Received 04/17/2001
Decision Date 06/05/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No