BLUEPHASE STYLE


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K110756
Device Name BLUEPHASE STYLE
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 872.6070
Classification Product Code
EBZ  
Date Received 03/18/2011
Decision Date 08/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls