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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K944286
Device Name METAL-LINED TRANSCEND CERAMIC BRACKET
Applicant
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact MARLYN SCHEFF
Correspondent
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact MARLYN SCHEFF
Regulation Number872.5470
Classification Product Code
DYW  
Date Received09/02/1994
Decision Date 11/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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