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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 K943245
Device Name SPIRIT MB
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1332 SOUTH LONE HILL AVE.
GLENDORA,  CA  91740
Applicant Contact JEFFREY A ANDERSON
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1332 SOUTH LONE HILL AVE.
GLENDORA,  CA  91740
Correspondent Contact JEFFREY A ANDERSON
Regulation Number872.5470
Classification Product Code
DYW  
Date Received07/06/1994
Decision Date 08/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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