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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name locator, root apex
510(k) Number K953867
Device Name ROOT CANAL LENGTH MEASURING DEVICE
Applicant
J. MORITA USA, INC.
9 MASON
IRVINE,  CA  92618
Applicant Contact TERRY G MAHN
Correspondent
J. MORITA USA, INC.
9 MASON
IRVINE,  CA  92618
Correspondent Contact TERRY G MAHN
Classification Product Code
LQY  
Date Received08/17/1995
Decision Date 12/01/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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