VENUS PEARL PLT REFILL A1


Device Classification Name

material, tooth shade, resin

510(k) Number K112501
Device Name VENUS PEARL PLT REFILL A1
Applicant
HERAEUS KULZER, LLC
300 heraeus way
south bend, 
IN 
46614

Applicant Contact cheryl zimmerman
Correspondent
HERAEUS KULZER, LLC
300 heraeus way
south bend, 
IN 
46614

Correspodent Contact cheryl zimmerman
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 08/30/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No