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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K011167
Device Name XSE
Applicant
3M Company
3m Center, Bldg. 260-2b-12
St Paul,  MN  55144
Applicant Contact KAREN O'MALLEY
Correspondent
3M Company
3m Center, Bldg. 260-2b-12
St Paul,  MN  55144
Correspondent Contact KAREN O'MALLEY
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/16/2001
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
Predetermined Change
Control Plan Authorized		 No
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