XSE


Device Classification Name

agent, tooth bonding, resin

510(k) Number K011167
Device Name XSE
Original Applicant
3M COMPANY
3m center, bldg. 260-2b-12
st paul, 
MN 
55144

Original Contact karen o’malley
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 04/16/2001
Decision Date 05/17/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No