SILJETR SYSTEM


Device Classification Name

material, tooth shade, resin

510(k) Number K110642
Device Name SILJETR SYSTEM
Applicant
DANVILLE MATERIALS INC.
3420 fostoria way st. a-200
san ramon, 
CA 
94583

Applicant Contact lindsay tilton
Correspondent
DANVILLE MATERIALS INC.
3420 fostoria way st. a-200
san ramon, 
CA 
94583

Correspodent Contact lindsay tilton
Regulation Number 872.3690
Classification Product Code
EBF  
Subsequent Product Codes
KLE   KOJ  
Date Received 03/07/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No