ION DENTAL RESIN SYSTEM


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K072713
Device Name ION DENTAL RESIN SYSTEM
Applicant
DENTSPLY INTERNATIONAL, INC.
221 w. philadelphia st.
suite 60
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNATIONAL, INC.
221 w. philadelphia st.
suite 60
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.3760
Classification Product Code
EBI  
Subsequent Product Code
MQC  
Date Received 09/25/2007
Decision Date 10/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No