BUTLER GUM PROPHY PASTE WITH NOVAMIN


Device Classification Name

agent, polishing, abrasive, oral cavity

510(k) Number K024343
Device Name BUTLER GUM PROPHY PASTE WITH NOVAMIN
Original Applicant
USBIOMATERIALS CORP.
13709 progress blvd.
#23
alachua, 
FL 
32615

Original Contact david c greenspan
Regulation Number 872.6030
Classification Product Code
EJR  
Date Received 12/27/2002
Decision Date 07/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No