SELF-ADHESIVE RESIN CEMENT


Device Classification Name

cement, dental

510(k) Number K073173
Device Name SELF-ADHESIVE RESIN CEMENT
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 872.3275
Classification Product Code
EMA  
Date Received 11/13/2007
Decision Date 01/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No