STERI-MATE STERILIZABLE HANDPIECE


Device Classification Name

scaler, ultrasonic

510(k) Number K023697
Device Name STERI-MATE STERILIZABLE HANDPIECE
Original Applicant
DENTSPLY INTERNATIONAL
p.o. box 872
570 west college ave.
york, 
PA 
17405

Original Contact p. jeffery lehn
Regulation Number 872.4850
Classification Product Code
ELC  
Date Received 11/04/2002
Decision Date 11/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No