RELYX LUTING PLUS AUTOMIX


Device Classification Name

cement, dental

510(k) Number K111185
Device Name RELYX LUTING PLUS AUTOMIX
Applicant
3M ESPE DENTAL PRODUCTS
3m center, building 260-2a-11
st. paul, 
MN 
55144 -1000

Applicant Contact bernardo medellin, j.d.
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 04/27/2011
Decision Date 05/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No