ESTELITE SIGMA QUICK


Device Classification Name

material, tooth shade, resin

510(k) Number K080940
Device Name ESTELITE SIGMA QUICK
Applicant
TOKUYAMA DENTAL CORPORATION
1425 k street, n.w. suite 1100
washington, 
DC 
20005

Applicant Contact keith barritt
Correspondent
TOKUYAMA DENTAL CORPORATION
1425 k street, n.w. suite 1100
washington, 
DC 
20005

Correspodent Contact keith barritt
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 04/03/2008
Decision Date 06/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No