PALFIQUE ESTELITE LV


the company

Device Classification Name

material, tooth shade, resin

510(k) Number K002863
Device Name PALFIQUE ESTELITE LV
Original Applicant
TOKUYAMA AMERICA, INC.
2000 m st. nw
suite 700
washington, 
DC 
20036

Original Contact daniel j manelli
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 09/13/2000
Decision Date 01/04/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No