PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES


Device Classification Name

agent, polishing, abrasive, oral cavity

510(k) Number K033449
Device Name PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
Applicant
PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC
500 white dr.
batesville, 
AR 
72501

Applicant Contact joann underwood
Correspondent
PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC
500 white dr.
batesville, 
AR 
72501

Correspodent Contact joann underwood
Regulation Number 872.6030
Classification Product Code
EJR  
Date Received 10/29/2003
Decision Date 01/07/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No