SURESMILE SYSTEM


definition

Device Classification Name

unit, operative dental

510(k) Number K002620
Device Name SURESMILE SYSTEM
Original Applicant
ORA METRIX, INC.
12740 hillcrest road, ste 100
dallas, 
TX 
75230

Original Contact nancy butcher
Regulation Number 872.6640
Classification Product Code
EIA  
Date Received 08/23/2000
Decision Date 11/16/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No