TETRIC EVOCERAM BULK FILL


Device Classification Name

material, tooth shade, resin

510(k) Number K111958
Device Name TETRIC EVOCERAM BULK FILL
Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

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

Correspodent Contact donna marie hartnett
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 07/11/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No