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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K180609
Device Name Rodo Smilekey
Rodo Medical, Inc.
6399 San Ignacio Ave., Suite 100
San Jose,  CA  95119
Applicant Contact Michael Parsons
Hogan Lovells US LLP
555 Thirteen Street NW
Washington,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number872.3630
Classification Product Code
Date Received03/08/2018
Decision Date 05/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No