SOFRELINER TOUGH S


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K112445
Device Name SOFRELINER TOUGH S
Applicant
TOKUYAMA DENTAL CORPORATION
1425 k street, n.w. suite 1100
washington, 
DC 
20005

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

Correspodent Contact keith a barritt
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 08/24/2011
Decision Date 10/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No