P2 POLYETHER


Device Classification Name

material, impression

510(k) Number K030318
Device Name P2 POLYETHER
Original Applicant
HERAEUS KULZER, INC.
4315 south lafayette blvd.
south bend, 
IN 
46614 -2517

Original Contact cheryl v zimmerman
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 01/30/2003
Decision Date 04/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls