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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K994357
Device Name BITEM LOCK, MODELS SW006, SW012
Applicant
THERMOELASTIC TECHNOLOGIES, INC.
3234 ELLA LN.
NEW PORT RICHEY,  FL  34655
Applicant Contact ART WARD
Correspondent
THERMOELASTIC TECHNOLOGIES, INC.
3234 ELLA LN.
NEW PORT RICHEY,  FL  34655
Correspondent Contact ART WARD
Regulation Number872.5410
Classification Product Code
EJF  
Date Received12/27/1999
Decision Date 03/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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