AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL


Device Classification Name

material, impression

510(k) Number K021413
Device Name AQUASIL ULTRA RIGID 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 05/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No