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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
Predetermined Change
Control Plan Authorized		 No
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