IPS EMPRESS DIRECT FLOW


Device Classification Name

material, tooth shade, resin

510(k) Number K103528
Device Name IPS EMPRESS DIRECT FLOW
Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Applicant Contact donna hartnett
Correspondent
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Correspodent Contact donna hartnett
Regulation Number 872.3690
Classification Product Code
EBF  
Subsequent Product Codes
EBC   EBD  
Date Received 11/30/2010
Decision Date 02/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No