THERMOFORM SHEET MATERIALS AND ACCESSORIES


Device Classification Name

mouthguard, prescription

510(k) Number K072522
Device Name THERMOFORM SHEET MATERIALS AND ACCESSORIES
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
Classification Product Code
MQC  
Date Received 09/07/2007
Decision Date 11/16/2007
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No