GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL


Device Classification Name

material, impression

510(k) Number K030414
Device Name GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
Applicant
SULTAN CHEMISTS, INC.
85 west forest ave.
englewood, 
NJ 
07631

Applicant Contact clark smith
Correspondent
SULTAN CHEMISTS, INC.
85 west forest ave.
englewood, 
NJ 
07631

Correspodent Contact clark smith
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 02/07/2003
Decision Date 04/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No