DIAMONDCOAT ULTRASONIC INSERTS


Device Classification Name

scaler, ultrasonic

510(k) Number K030111
Device Name DIAMONDCOAT ULTRASONIC INSERTS
Original Applicant
DENTSPLY INTERNATIONAL
570 west college ave.
york, 
PA 
17405

Original Contact p. jeffery lehn
Regulation Number 872.4850
Classification Product Code
ELC  
Date Received 01/13/2003
Decision Date 02/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No