MICROFILL 13


Device Classification Name

material, tooth shade, resin

510(k) Number K022972
Device Name MICROFILL 13
Original Applicant
AB ARDENT
54 riverview ave.
tonawanda, 
NY 
14150 -5260

Original Contact clyde e ingersoll
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 09/06/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No