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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K991283
Device Name DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
Applicant
MICRO MOTORS, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606 -1849
Applicant Contact KAREN U SALINAS
Correspondent
MICRO MOTORS, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606 -1849
Correspondent Contact KAREN U SALINAS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/15/1999
Decision Date 08/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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