STANDOUT 2


Device Classification Name

material, impression

510(k) Number K072622
Device Name STANDOUT 2
Applicant
KERR CORP.
1717 w. collins avenue
orange, 
CA 
92867

Applicant Contact wendy garman
Correspondent
KERR CORP.
1717 w. collins avenue
orange, 
CA 
92867

Correspodent Contact wendy garman
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 09/17/2007
Decision Date 12/04/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No