PROLINK ADHESIVES (PROLINK, PROLINK SE)


Device Classification Name

agent, tooth bonding, resin

510(k) Number K110403
Device Name PROLINK ADHESIVES (PROLINK, PROLINK SE)
Applicant
SILMET LTD.
12 hassadna st.
or yehuda, 

IL

60200

Applicant Contact moshe zalsman
Correspondent
SILMET LTD.
12 hassadna st.
or yehuda, 

IL

60200

Correspodent Contact moshe zalsman
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 02/11/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No