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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 K073045
Device Name SAPPHIRE CERAMIC BRACKET
Applicant
ORTHO TECHNOLOGY, INC
17401 COMMERCE PARK BLVD.
TAMPA,  FL  33647
Applicant Contact PAUL WILLIAMS
Correspondent
ORTHO TECHNOLOGY, INC
17401 COMMERCE PARK BLVD.
TAMPA,  FL  33647
Correspondent Contact PAUL WILLIAMS
Regulation Number872.5470
Classification Product Code
NJM  
Date Received10/29/2007
Decision Date 12/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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