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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K101481
Device Name BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
Applicant
BIOMERS PRODUCTS, LLC
18912 NORTH CREEK PARKWAY
SUITE 210
BOTHELL,  WA  98011
Applicant Contact GEORGE ALIPHTIRAS
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Regulation Number872.5470
Classification Product Code
NJM  
Date Received05/28/2010
Decision Date 06/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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