PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K110037
Device Name PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID
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 872.3760
Classification Product Code
EBI  
Date Received 01/06/2011
Decision Date 04/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No