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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, impression
510(k) Number K030776
Device Name MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
Applicant
DISCUS DENTAL, INC.
8550 HIGUERA ST.
CULVER CITY,  CA  90232 -2522
Applicant Contact YOGI SHAH
Correspondent
DISCUS DENTAL, INC.
8550 HIGUERA ST.
CULVER CITY,  CA  90232 -2522
Correspondent Contact YOGI SHAH
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/11/2003
Decision Date 05/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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