PRIMAFLOW


the company

Device Classification Name

material, tooth shade, resin

510(k) Number K002086
Device Name PRIMAFLOW
Original Applicant
DMG USA, INC.
5 whitcomb ave.
ayer, 
MA 
01432

Original Contact pamela papineau
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 07/10/2000
Decision Date 08/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Abbreviated
Reviewed by Third Party No

Combination Product

No