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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Band, Preformed, Orthodontic
510(k) Number K872471
Device Name TITANE SL DENTAL BURR
Applicant
Titane SL Co.
Suite 1109
111 Marquette Ave. S.
Minneapolis,  MN  55401
Applicant Contact R LEITGEN
Correspondent
Titane SL Co.
Suite 1109
111 Marquette Ave. S.
Minneapolis,  MN  55401
Correspondent Contact R LEITGEN
Regulation Number872.5410
Classification Product Code
ECM  
Date Received06/23/1987
Decision Date 09/11/1987
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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