IMPRESSION COMPOUND


Device Classification Name

material, impression

510(k) Number K110378
Device Name IMPRESSION COMPOUND
Applicant
SPOFADENTAL
1717 west collins avenue
orange, 
CA 
92867

Applicant Contact wendy garman
Correspondent
SPOFADENTAL
1717 west collins avenue
orange, 
CA 
92867

Correspodent Contact wendy garman
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 01/12/2011
Decision Date 04/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No