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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Alloy, Metal, Base
510(k) Number K950951
Device Name NEOCAST C, V, S
Applicant
Neodontics, Inc.
11805 Teale St.
Culver City,  CA  90230
Applicant Contact JERRY JAWORSKI
Correspondent
Neodontics, Inc.
11805 Teale St.
Culver City,  CA  90230
Correspondent Contact JERRY JAWORSKI
Regulation Number872.3710
Classification Product Code
EJH  
Date Received03/02/1995
Decision Date 03/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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