XERACEM


Device Classification Name

cement, dental

510(k) Number K081405
Device Name XERACEM
Applicant
DOXA DENTAL AB
555 thirteenth street nw
columbia square
washington, 
DC 
20004

Applicant Contact jonathan kahan
Correspondent
DOXA DENTAL AB
555 thirteenth street nw
columbia square
washington, 
DC 
20004

Correspodent Contact jonathan kahan
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 05/19/2008
Decision Date 08/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No