IBOND GLUMA INSIDE


Device Classification Name

agent, tooth bonding, resin

510(k) Number K022612
Device Name IBOND GLUMA INSIDE
Original Applicant
HERAEUS KULZER, INC.
4315 south lafayette blvd.
south bend, 
IN 
46614 -2517

Original Contact cheryl v zimmerman
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 08/06/2002
Decision Date 10/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No