TEMPFLEX


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K110747
Device Name TEMPFLEX
Applicant
KERR CORPORATION
1717 west collins avenue
orange, 
CA 
92867

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

Correspodent Contact wendy garman
Regulation Number 872.3770
Classification Product Code
EBG  
Date Received 03/17/2011
Decision Date 06/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No