DENTIN DESENSITIZER AGENT


Device Classification Name

varnish, cavity

510(k) Number K073117
Device Name DENTIN DESENSITIZER AGENT
Applicant
DENTSPLY INTL., INC.
susquehanna commerce center
221 w philadelphia st. ste 60
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTL., INC.
susquehanna commerce center
221 w philadelphia st. ste 60
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.3260
Classification Product Code
LBH  
Date Received 11/05/2007
Decision Date 12/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No