Z BOND, PRELUDE ONE


Device Classification Name

agent, tooth bonding, resin

510(k) Number K111876
Device Name Z BOND, PRELUDE ONE
Applicant
DANVILLE MATERIALS, INC.
3420 fostoria way, suite a-200
san ramon, 
CA 
94583

Applicant Contact lindsay tilton
Correspondent
DANVILLE MATERIALS, INC.
3420 fostoria way, suite a-200
san ramon, 
CA 
94583

Correspodent Contact lindsay tilton
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 07/01/2011
Decision Date 09/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No