MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K080311
Device Name MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM
Applicant
DENTSPLY INTERNTIONAL
221 w. philadelphia st. ste.60
susquehanna commerce crt. west
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNTIONAL
221 w. philadelphia st. ste.60
susquehanna commerce crt. west
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.3770
Classification Product Code
EBG  
Subsequent Product Code
EBD  
Date Received 02/06/2008
Decision Date 04/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No