AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL


Device Classification Name

material, impression

510(k) Number K021416
Device Name AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
Original Applicant
DENTSPLY INTL.
570 west college ave.
york, 
PA 
17405 -0872

Original Contact p. jeffery lehn
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 05/03/2002
Decision Date 05/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No