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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 K052245
Device Name ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
Applicant
Lar Mfg., LLC
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Applicant Contact IAN P GORDON
Correspondent
Lar Mfg., LLC
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Correspondent Contact IAN P GORDON
Regulation Number872.5470
Classification Product Code
NJM  
Date Received08/17/2005
Decision Date 09/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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