NEUN


Device Classification Name

material, tooth shade, resin

510(k) Number K073554
Device Name NEUN
Applicant
HERAEUS KULZER GMBH
4315 south lafayette blvd.
south bend, 
IN 
46614 -2517

Applicant Contact cheryl v zimmerman
Correspondent
HERAEUS KULZER GMBH
4315 south lafayette blvd.
south bend, 
IN 
46614 -2517

Correspodent Contact cheryl v zimmerman
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 12/18/2007
Decision Date 02/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No